Hyaline cartilage shaping

ABSTRACT

Disclosed embodiments include devices and methods for shaping, bending, and/or volumetrically reducing rigid cartilaginous structures, such as hyaline cartilage in the septum. In the case of septal cartilage, shaping, bending, or reducing the cartilage would be useful for reducing nasal obstruction or to improve the cosmetic appearance of the nose.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/429,947, filed Feb. 10, 2017, which claims the benefit of U.S.Provisional Application No. 62/294,724, filed on Feb. 12, 2016, and U.S.Provisional Application No. 62/335,802, filed on May 13, 2016. Thedisclosures of these priority applications are hereby incorporated byreference in their entireties herein.

Embodiments described in this application may be used in combination orconjunction with the subject matter described in the followingapplications, which are hereby fully incorporated by reference for anyand all purposes as if set forth herein in their entireties: U.S. patentapplication Ser. No. 14/026,922, filed Sep. 13, 2013, entitled “METHODSAND DEVICES TO TREAT NASAL AIRWAYS,” issued Mar. 24, 2015, as U.S. Pat.No. 8,986,301; U.S. patent application Ser. No. 14/675,689, filed Mar.31, 2015, entitled “POST NASAL DRIP TREATMENT,” issued Aug. 16, 2016, asU.S. Pat. No. 9,415,194; and U.S. patent application Ser. No.15/175,651, filed Jun. 7, 2016, entitled “PRESSURE SENSITIVE TISSUETREATMENT DEVICE,” issued on Feb. 13, 2018 as U.S. Pat. No. 9,888,957.

FIELD OF THE INVENTION

This application relates generally to the field of medical devices andtreatments, and in particular to systems, devices and methods fortreating tissue, such as the hyaline cartilage of structures within thenose and upper airway.

BACKGROUND

During respiration, the anatomy, shape, tissue composition, andproperties of the human airway produce airflow resistance. The nose isresponsible for almost two thirds of this resistance. Most of thisresistance occurs in the anterior part of the nose, known as theinternal nasal valve, which acts as a flow-limiter. The external nasalvalve structure also causes resistance to nasal airflow. Effectivephysiological normal respiration occurs over a range of airflowresistances. However, excessive resistance to airflow can result inabnormalities of respiration that can significantly affect a patient'squality of life. Poor nasal breathing and/or nasal congestion hasprofound effects on a person's health and quality of life, which can bemeasured by validated questionnaires, such as the NOSE score, asdescribed in Stewart M G, Witsell D L, Smith T L, Weaver E M, Yueh B,and Hannley M T., “Development and Validation of the Nasal ObstructionSymptom Evaluation (NOSE) Scale,” Otolaryngol Head Neck Surg 2004;130:157-63.

Inadequate nasal airflow can result from a number of conditions causingan inadequate cross-sectional area of the nasal airway in the absence ofany collapse or movement of the cartilages and soft tissues of the nasalairway. A common cause of inadequate nasal airflow is deviation of thenasal septum. The nasal septum is a wall of tissue that separates thenasal cavity into two nostrils. The septum is made up of bone, hyalinecartilage, and nasal mucosa. The American Academy of Otolaryngologyestimates that many as 80% of adults have a nasal septum that isslightly off center. A more severe shift away from the midline of thenose, known as a deviated septum, frequently results in difficultybreathing and can often precipitate chronic sinusitis. The most commonmeans of correcting a deviation is partial or full removal of the nasalseptum, known as a septoplasty. More than 250,000 septoplasties areperformed in the United States each year. Although septoplasty can be aneffective treatment, it is also quite invasive, can lead to a painfuland difficult recovery, and is associated with a number of risks andpotential side effects, as with any invasive surgical procedure. It isestimated that only about 10% of patients with a deviated septum willelect to have surgery, in part due to the risks and invasiveness of theprocedure.

Therefore, it would be advantageous to have improved methods and devicesfor treating a deviated septum, to help improve breathing and/oralleviate other symptoms in a patient. Ideally, such methods and deviceswould provide a non-surgical, minimally invasive or less invasiveapproach for correcting deviated septa and thus would provide patientswith a less painful alternative treatment, with fewer risks and sideeffects and easier recovery. At least some of these objectives areaddressed by the embodiments described in this application.

SUMMARY

Embodiments of the present application are directed to devices, systemsand methods for treating nasal airways. Such embodiments may be used toimprove breathing by decreasing airflow resistance or perceived airflowresistance in the nasal airways. For example, the devices, systems andmethods described herein may be used to reshape, remodel, strengthen, orchange the properties of the tissues of the nose, including, but notlimited to the skin, muscle, mucosa, submucosa and cartilage in the areaof the nasal septum.

The nasal septum forms a portion of the nasal valve. The nasal valve isdivided into external and internal portions. The external nasal valve isthe external nasal opening formed by the columella at the base of theseptum, the nasal floor, and the nasal rim (the lower region of thenasal wall, also known as the caudal border of the lower lateralcartilage). The nasalis muscle dilates the external nasal valve portionduring inspiration. The internal nasal valve, which accounts for a largepart of the nasal resistance, is located in the area of transitionbetween the skin and respiratory epithelium. The internal nasal valvearea is formed by the nasal septum, the caudal border of the upperlateral cartilage (ULC), the head of the inferior turbinate, and thepyriform aperture and the tissues that surround it. An angle formedbetween the caudal border of the ULC and the nasal septum is normallybetween about 10 degrees and about 15 degrees, as illustrated in FIG. 1.

In one aspect, a method for modifying a nasal septum of a subject's nosemay involve: applying a solution to the nasal septum, where the solutionis configured to modify cartilage of the nasal septum; providing a timeperiod for the solution to modify the cartilage; inserting a device intothe subject's nose; applying energy to the nasal septum using thedevice; reshaping the cartilage using the device; and removing thedevice.

In various embodiments, the solution may be collagenase, hyaluronidase,tosyl lysyl chloromethane, trypsin, trypsin/EDTA, or some combinationthereof. In some embodiments, the solution is configured to soften thecartilage of the nasal septum. In some embodiments, the solution isconfigured to dissolve proteoglycan structures of the cartilage. In oneembodiment, for example, the solution may include about 0.5 ml to 2.5 mlof collagenase at a concentration ranging from about 1 mg/ml to 10mg/ml. In another embodiment, the solution may include between about 0.5ml to 2.5 ml of trypsin at a concentration of about 10 μg/ml to about100 μg/ml.

In some embodiments, the time period for the solution to modify thecartilage may be between about 15 minutes to about 90 minutes. In someembodiments, providing the time period for the solution to modify thecartilage may involve providing a time period for the solution to createa band of degraded cartilage ranging from about 100 μm to about 1 mmfrom a surface of the cartilage. In some embodiments, applying thesolution may involve injecting the solution into or near the cartilage.In some embodiments, injecting the solution into or near the cartilagemay involve injecting the solution through nasal mucosal tissue to aspace between the nasal mucosa and the cartilage.

Optionally, the method may also involve defining an area of applicationof the solution by providing a physical barrier to contain the appliedsolution. In some embodiments, applying energy to the nasal septum usingthe device may involve heating tissue of the nasal septum. In someembodiments, the method may include heating tissue of the nasal septumto a temperature selected to denature or deactivate the solution. Insome embodiments, the device may include a radiofrequency electrode. Insome embodiments, reshaping the cartilage using the device may involvecorrecting a septal deviation.

In another aspect, a method for treating a deviated nasal septum in apatient's nasal cavity may involve applying a cartilage modifyingsubstance to cartilage of the deviated nasal septum and applying energyto the nasal septum via an energy delivery device to treat the deviatednasal septum. Optionally, the method may also involve allowing thesubstance to remain in the cartilage of the nasal septum for apredetermined time period before applying the energy. For example, invarious embodiments, the predetermined time period may be between about15 minutes and about 90 minutes.

In various embodiments, the substance may be any of collagenase,hyaluronidase, tosyl lysyl chloromethane, trypsin, trypsin/EDTA, or acombination thereof. In some embodiments, the substance may be acollagen softening substance. In some embodiments, the substance may bea proteoglycan dissolving substance. One embodiment of a substance maybe about 0.5 ml to about 2.5 ml of collagenase at a concentrationranging from about 1 mg/ml to about 10 mg/ml. Another embodiment of asubstance may be between about 0.5 ml to about 2.5 ml of trypsin at aconcentration of about 10 μg/ml to about 100 μg/ml.

In some embodiments, applying the substance may involve injecting thesubstance into or near the cartilage. For example, some embodiments mayinvolve injecting the substance through nasal mucosal tissue to a spacebetween the nasal mucosa and the cartilage. Optionally, the method mayalso include forming a physical barrier within the patient's nasalcavity to contain the applied substance in or near the nasal septum.

The energy applied may be any suitable energy, such as but not limitedto radiofrequency, heat, electrical, ultrasound, microwave and/orcryogenic energy. In some embodiments, applying energy to the nasalseptum may involve heating tissue of the nasal septum to a temperatureselected to denature or deactivate the substance. In some embodiments,the method may also involve applying pressure to the nasal septum, usingthe energy delivery device, to reshape the septum. In some embodiments,the substance may be applied via the energy delivery device. Inalternative embodiments, it may be applied with a separate device, suchas a needle and syringe. In various embodiments, the cartilage of thenasal septum may include hyaline cartilage.

In some embodiments, correcting a deviated septum of a subject's nosemay involve applying a solution to a nasal septum of a subject's nosehaving a deviation. The solution may be configured to modify cartilageof the nasal septum. Correcting a deviated septum may further involveinserting a device into the subject's nose such that a first treatmentelement of the device is positioned on a side of septum and a secondtreatment element of the device is positioned on an opposite side of theseptum. Correcting a deviated septum may further involve applying energyto the nasal septum using the first treatment element or the secondtreatment element. Correcting a deviated septum may further involvereshaping the cartilage using the first treatment element and the secondtreatment element, thereby correcting the deviated nasal septum.

In some embodiments, treating a deviated septum may involve inserting adevice into a subject's nose having a deviation, the device having anelongate treatment element. Treating a deviated septum may also involvecreating an air channel in the deviation using the elongate treatmentelement of the device, thereby reducing the deviation and improvingairflow. Treating a deviated septum may further involve removing thedevice from the subject's nose. The air channel in the deviation maypersist after the device is removed.

In some embodiments, treating a deviated septum may involve applying asolution to the nasal septum having a deviation. The solution may beconfigured to modify cartilage of the nasal septum. Treating a deviatedseptum may further involve providing a dwell time for the solution tomodify cartilage of the nasal septum. Treating a deviated septum mayfurther involve removing the modified cartilage of the nasal septum,thereby treating the deviated septum of the subject's nose.

In some embodiments, a device for treating a deviated septum of asubject's nose, may include a handle, an elongate shaft extending fromthe handle, and an elongate treatment element extending from theelongate shaft and configured to create channels in the deviated septumof the subject's nose. The elongate treatment element can be configuredto apply energy to or remove energy from tissue of the deviated septumof the subject's nose. The device can include multiple pairs of bipolarelectrodes arranged in a serial alignment along the treatment element.The pairs of bipolar electrodes can be arranged with the center of theelectrodes along a longitudinal axis of the treatment element.

These and other aspects and embodiments will be described in furtherdetail below, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 depicts an illustration of bone and cartilage structures of ahuman nose.

FIG. 2A shows a cross-sectional view, illustrating tissues andstructures of a human nose.

FIG. 2B shows a detailed cross-sectional view, illustrating a detailedsection of the structures of FIG. 2A.

FIG. 2C shows a view of the nostrils, illustrating tissues andstructures of a human nose.

FIG. 3 depicts a schematic illustration of a nasal septum reshapingtreatment device.

FIG. 4A is a perspective illustration of an embodiment of a treatmentelement shape.

FIG. 4B depicts a perspective illustration of another embodiment of atreatment element shape.

FIG. 4C shows a perspective illustration of another embodiment of atreatment element shape.

FIG. 4D depicts a cross-sectional view of a treatment device comprisinga plurality of microneedles puncturing tissue in order to applytreatment at a desired tissue depth.

FIG. 5A illustrates one embodiment of a clamp-type nasal septumtreatment device.

FIG. 5B illustrates another embodiment of a clamp-type nasal septumtreatment device.

FIG. 6 depicts a partially-transparent perspective view, showing a stentimplanted in a nose.

FIG. 7 depicts a perspective view, illustrating an energy deliveryballoon being inserted into a nose.

FIGS. 8A-8J depict embodiments of various electrode arrangements forapplying energy to the nasal septum area.

FIGS. 9A and 9B illustrate embodiments of devices for applying energy tothe nasal septum area using a monopolar electrode.

FIGS. 10A and 10B illustrate an embodiment of a device for applyingenergy to the nasal septum area using a monopolar electrode and anexternal mold.

FIGS. 11A and 11B illustrate embodiments of devices for applying energyto the nasal septum area using electrode(s) and a counter-tractionelement.

FIGS. 12A and 12B illustrate embodiments of devices for applying energyto the nasal septum area and configured to be inserted into bothnostrils simultaneously.

FIGS. 13A-13E illustrate embodiments of devices for applying energy tothe nasal septum area configured to be inserted into both nostrilssimultaneously, having a mold or counter-traction element for engagingthe nose externally.

FIGS. 14A and 14B illustrate embodiments of devices for applying energyto the nasal septum area configured to be inserted into both nostrilssimultaneously, having separate external molds.

FIGS. 15A-15C illustrate embodiments of devices for applying energy tothe nasal septum area configured to be inserted into both nostrilssimultaneously, having separate counter-traction elements.

FIG. 16 shows an embodiment of a system comprising a device for applyingenergy to the nasal septum area with an external electrode and aseparate internal mold.

FIGS. 17A and 17B illustrate an embodiment of a device for applyingenergy to the nasal septum area comprising an external electrode and aninternal mold.

FIG. 18 shows an embodiment of a device for applying energy to the nasalseptum area comprising an array of non-penetrating electrodes.

FIGS. 19A and 19B illustrate an embodiment of a device for applyingenergy to the nasal septum area configured for use in only one nostril.

FIGS. 20A and 20B illustrate an embodiment of a device for applyingenergy to the nasal septum area configured for use in either nostril.

FIGS. 21A and 21B illustrate an embodiment of a device for applyingenergy to the nasal septum area having a symmetrical shape.

FIGS. 22A-22G illustrate an embodiment of a device for applying energyto the nasal septum area using a monopolar electrode.

FIGS. 23A-23G illustrate an embodiment of a device for applying energyto the nasal septum area using an array of needle electrodes.

FIG. 24A depicts a cross-section of tissue at the nasal septum.

FIG. 24B depicts heat effects of RF treatment of tissue at the nasalseptum.

FIGS. 25A and 25B illustrate embodiments of devices for applying energyto the nasal septum area incorporating cooling systems.

FIG. 26 shows an embodiment of a device for applying energy to the nasalseptum area incorporating a heat pipe.

FIG. 27 depicts an embodiment of a device for applying energy to thenasal septum area incorporating heat pipes.

FIGS. 28A-28E depict embodiments of differential cooling mechanisms.

FIG. 29 shows an embodiment of a system comprising a device for applyingenergy to the nasal septum area with electrode needles and a separatecooling mechanism.

FIGS. 30A-30D show an embodiment of a method for modifying a nasalseptum.

FIGS. 30E-30H show an embodiment of a method for applying energy to thenasal septum area using a device for applying energy to the nasal septumarea.

FIGS. 31A and 31B are a perspective view and a side, cross-sectionalview, respectively, of a device for applying energy to the nasal septumarea, including an internal power source, according to one embodiment.

FIGS. 32A and 32B are a cross-sectional side view of facial skin and afront view of a face of a patient, respectively, illustrating use ofvarious embodiments of sensors that may be part of a system for applyingenergy to the nasal septum area, according to one embodiment.

FIGS. 33A and 33B are a bottom view of a distal end of a treatmentdevice and a cross-sectional view of a nasal passage, respectively,illustrating wings of the treatment device that may be used to helpguide the distal end to a desired location in the nasal passage.

FIGS. 34A-34C are top views of various alternative embodiments of distalends of treatment devices having different shapes for addressingdifferently shaped tissues.

FIG. 35 is a top view of a treatment device and a cross-sectional viewof a portion of a nose, in which the treatment device includes anexpandable member, according to one embodiment.

FIGS. 36A-36E illustrate a method and device for treating a septumhaving a deviation, according to some embodiments.

FIG. 37 illustrates a channel stylus device that may be used to treat adeviated septum, according to some embodiments.

FIGS. 38A-38C illustrate a method of treating a septum having adeviation using a channel stylus device, according to some embodiments.

FIGS. 39A-39D illustrate a method of treating a deviated septum bytreating and evacuating cartilage, according to some embodiments.

DETAILED DESCRIPTION

The following disclosure provides embodiments of systems and methods forshaping, bending, and/or volumetrically reducing rigid cartilaginousstructures, such as hyaline cartilage in a nasal septum. In the case ofseptal cartilage, shaping, bending, or reducing the cartilage would beuseful for reducing nasal obstruction or to improve the cosmeticappearance of the nose. The treatment may improve breathing bycorrecting deviations in a subject's nasal septum, thereby decreasingairflow resistance or perceived airflow resistance.

Treatment of hyaline cartilage of the nasal septum presents severalunique challenges, any or all of which may be addressed by theembodiments described in this application. For example, shaping andbending of hyaline cartilage may be difficult, due to its stiff andbrittle nature. Further, some techniques that are effective atdisrupting the matrix of elastic cartilage of certain portions of thenasal valve may not be effective at reshaping hyaline cartilage in thenasal septum, which may need more than the application of energy alonefor modification. Disclosed embodiments may provide for modifyinghyaline cartilage by, for example, providing methods and devices forsoftening the cartilage of the nasal septum (e.g., by applying asolution at or near the nasal septum) in addition to reshaping,remodeling, or changing the properties of the tissues.

While, in some instances, nasal dysfunction can lead to poor airflow,nasal breathing can also be improved in people with normal breathingand/or normal nasal anatomy by decreasing nasal airflow resistance inthe nasal valve and associated nasal anatomy. Remodeling or changing thestructure of the nasal septum can improve nasal airflow. Prior methodsand systems generally involve invasive methods or unsightly devices thata person with normal breathing and/or anatomy may not necessarily beinclined to use or undergo. Thus, there remains an unmet need in the artfor non-invasive and minimally invasive methods and devices to decreasenasal airflow resistance or perceived nasal airflow resistance and/or toimprove nasal airflow or perceived nasal airflow and the resultingsymptoms or sequella of poor nasal airflow—including but not limited tosnoring, sleep disordered breathing, perceived nasal congestion and poorquality of life—through the change of structures within the nose thatform the passageways for airflow. Methods and devices described hereinmay be used to treat nasal airways or other cartilaginous areas withoutthe need for more invasive procedures (e.g., ablation or surgery).

Nasal breathing can be improved in people with normal breathing and/ornormal nasal anatomy by decreasing nasal airflow resistance or perceivednasal airflow resistance in the nasal valve and associated nasalanatomy. Restructuring the shape, conformation, angle, strength, andcross sectional area of the nasal septum may improve nasal airflow.Changing the nasal septum can be performed alone or together with otherprocedures (e.g., surgical procedures), such as those described above.Such methods and devices can lead to improved nasal airflow and/orincreased volume of nasal airflow in patients with normal or reducednasal airflow.

FIGS. 1 and 2A-C illustrate anatomical elements of a human nose. Thelower lateral cartilage (LLC) includes an external component referred toas the lateral crus and an internal component referred to as the medialcrus. The medial crus and septal nasal cartilage create a nasal septumthat separates the left and right nostrils. Upper lateral cartilage liesbetween the lower lateral cartilages and the nasal bone. The left ULC isseparated from the right ULC by the septal cartilage extending down thebridge of the nose. The opposing edges of the LLC and ULC may moverelative to one another. Disposed between the opposing edges is anaccessory nasal cartilage. The septal nasal cartilage and the ULC forman angle (θ) called the nasal valve angle.

FIG. 2B illustrates a detailed cross-section of a segment of nose tissuein the area of the intersection of the ULC and the LLC. As shown in thedetailed view of FIG. 2A, both inner and outer surfaces of the nasalcartilage are covered with soft tissue including mucosa, sub-mucosa andskin.

FIG. 2C illustrates a view of the nose as seen from the nostrils. FIG. 2depicts the nasal valve 1 shown between the septum 2 and the ULC 3. FIG.2A also depicts the position of the turbinate 4.

The internal nasal septum area of the nasal airway passage can bevisualized prior to and/or during any treatment by any suitable method,including but not limited to direct visualization, endoscopicvisualization, visualization by the use of a speculum,transillumination, ultrasound, MRI, x-ray or any other method. In someembodiments, treatments of the nasal septum area as described herein maybe performed in conjunction with or following another procedure (e.g., asurgical procedure such as rhinoplasty and/or modification of the nasalvalve). In such embodiments, the nasal septum area may be visualized andaccessed during surgery. In some embodiments, it may be desirable tovisualize the internal nasal septum with minimum disturbance, so as toavoid incorrect assessments due to altering the shape of the nasalseptum during visualization. In some embodiments, visualization elementsmay be incorporated into or combined with treatment devices configuredfor treating internal and/or external nasal septum.

Airflow through the nasal passage can be measured prior to and/or duringany treatment by any suitable method, including, but not limited to, anasal cannula connected to a pressure measurement system,rhinomanometry, and rhino-hygrometer. Nasal airflow and resistance canalso be evaluated by subjective evaluation before and after amanipulation to increase the cross-sectional area of the nasal passage,such as the Cottle maneuver. In some embodiments, it may be desirable tomeasure nasal airflow and/or resistance prior to, during and/or after aprocedure.

The nasal septum area of the nasal airway passage can be accessedthrough the nares. In some embodiments, one or more devices may be usedto pull the tip of the nose caudally and increase the diameter of thenares in order to further facilitate access to the nasal septum fortreatment. Such devices may include speculum type devices andretractors. In other embodiments, access to the nasal septum may also beachieved endoscopically via the nares, or via the mouth and throat. Insome embodiments, visualization devices may be incorporated or combinedwith treatment devices for treating internal and/or external nasalvalves. These and any other access and/or visualization devices may beused with any of the methods and devices below.

Some embodiments below provide apparatus and methods for modifyingcartilage, such as hyaline cartilage. Some embodiments below provideapparatus and methods for modifying the nasal septum and/or modifyingthe structure and/or structural properties of tissues at or adjacent tothe nasal septum.

In some embodiments, airflow restrictions to the internal nasal valvemay be the result of a smaller-than-optimal internal nasal valve angle,shown as θ in FIG. 2A. An internal nasal valve angle (i.e., the angleformed between the caudal border of the ULC and the nasal septum) ofless than the normally optimal range of between about 10 degrees andabout 15 degrees can result in airflow restrictions. Thus, in someembodiments, treatments may be designed to reshape structures at oradjacent to the nasal septum in order to increase the internal nasalvalve angle sufficiently that after such treatments, the nasal valveangle falls within the optimal range of about 10-15 degrees. In someembodiments, the internal valve angle may also be increased to begreater than 15 degrees.

In some embodiments, airflow restrictions to the internal nasal valvemay be the result of a smaller-than-optimal area of the internal nasalvalve. An internal nasal valve with a less than optimal area can resultin airflow restrictions. Thus, in some embodiments, treatments may bedesigned to reshape structures at or adjacent to the nasal septum inorder to increase the internal nasal valve angle sufficiently that aftersuch treatments, the area of the nasal valve falls within an optimalrange. In some embodiments, modifying the nasal septum withoutincreasing the angle of the nasal valve may improve airflow. In someembodiments, increasing the angle of the nasal valve without increasingthe area of the opening at the nasal valve may improve airflow. In someembodiments, both the opening at the area of the nasal valve and theangle of the nasal valve may be increased to improve airflow.

In some embodiments, nasal airflow can be increased in the presence ofnormal nasal anatomy and/or normal or enlarged nasal valve angle orarea.

With reference to FIG. 2A, in some embodiments, the internal valve angleθ or area may be increased by mechanically pressing against the nasalseptum. In some embodiments, this pressing may be performed by aninflatable balloon (such as those discussed below with reference toFIGS. 4A-4B), which may be positioned between the upper portion of thenasal septum 20 and the outer lateral wall 22 and then inflated,pressing against the nasal septum until the nasal valve angle reaches adesired size. Similarly, other mechanical devices such as spreaders orretractors (such as those discussed below with reference to FIGS. 5A and5B) or molds may be used. In alternative embodiments, short-termremovable implants may be used to reshape the nasal septum. Someexamples of short-term implants may include stents, molds or plugs. Infurther alternative embodiments, external reshaping elements, such asadhesive strips or face masks may be used to modify the shape of a nasalvalve and/or septum. In some embodiments, energy application or othertreatments as described below may be applied to substantially fix thereshaped tissue in a desired conformational shape before, during orafter applying a mechanical reshaping force (e.g., with the balloon,mechanical devices, molds, short-term implants, or external reshapingelements described above or any of the mechanical devices describedbelow).

In some embodiments, before, during or after reshaping the nasal tissue,the cartilage of the septum may be softened or otherwise modified. Acartilage softening or dissolving agent may be used to pre-treatcartilage, allowing it to be subsequently bent, shaped and/or reduced byenergy application(s) and/or mechanical force. The cartilage may besoftened at a surface of the tissue, so as to maintain the mechanicalintegrity of the nose as a whole but still enable sufficient reshaping,to alleviate the symptoms of a deviation. In some embodiments, thepre-treatment may substantially soften and/or dissolve the cartilage,such that the mechanical integrity of the cartilage is compromised.

In one embodiment, the cartilage may be treated with solutions viainjections, topical applications, or direct infusions from the surfaceor surfaces of a device. The solutions may be selected to modifyproperties of the cartilage for subsequent modification. The solutionsmay include, but are not limited to collagenase, hyaluronidase, tosyllysyl chloromethane, trypsin, trypsin/EDTA, and/or combinations thereof.Collagenase and trypsin are naturally occurring enzymes in the humanbody.

In the case of trypsin, proteoglycan structures of cartilage may bedissolved, leaving a compliant collagen matrix that may be subsequentlyheated, such as with radiofrequency energy. Heating the compliant matrixmay denature, and thus shrink or bend, the cartilage into a morefavorable position. Moreover, the heating can be used to stop thepropagation of proteoglycan digestion by rendering the trypsin inactive.

In another method, collagenase may be used to digest both theproteoglycan and collagen matrix of the cartilage. Remaining cartilageand other tissues may then be shaped or further reduced as necessaryusing radiofrequency heating or by other energy modalities.

In one embodiment, a device may be configured to inject the solutioninto or near the tissue to be treated. The device may define the area ofapplication to the cartilage by amount and number of sites injectedand/or by providing a physical barrier, such as a ring pressed againstthe nasal mucosa that corrals/contains the injected enzyme between themucosa and the cartilage.

As described above, the solution (e.g., a tissue dissolving agent) maybe applied to the tissue (e.g., cartilage) via injections, topicalapplications, transmucosal delivery devices, and/or other manners. Oncethe agent has affected the tissue, a heating device is used to reduceand/or shape the tissue by applying energy/heat to the target area. Thedevice is inserted into the nose and held against the target tissue, oralternately applied via a transmucosally inserted device. The energy isapplied, and then the device is removed (e.g., once all target tissuehas been treated).

In one embodiment, the heating device may be an RF Stylus. The stylusmay include a single- or multi-electrode head, which is configured toapply RF energy to the septal cartilage through the nasal mucosa. Thedevice may also be capable of measuring tissue temperature, impedance,wattage, and/or other properties to effectively alter power to thestylus to maintain desired RF energy and temperature.

In another embodiment, a reshaping device may be used to expand thediameter of the nasal passage at the nasal septum. The expansion devicecan be a balloon, a user controlled mechanical device, a self-expandingmechanical device, a fixed shape device, or any combination thereof. Theexpansion can increase the diameter over the normal range, in order forthe diameter to remain expanded after removal of the device and healingof the tissue.

In some embodiments, a reshaping device may be used to conformationallychange the structure of the nasal septum anatomy to allow greaterairflow, without necessarily expanding the diameter of the nasalpassage.

In some embodiments, a reshaping or remodeling device can be used toconformationally change the structure of areas of the nasal septum thatcauses the cross sectional or three dimensional structure of the nasalairway to assume a shape less restrictive to airflow without wideningthe nasal valve angle.

In some embodiments, energy may be applied in the form of heat,radiofrequency (RF), laser, light, ultrasound (e.g. high intensityfocused ultrasound), microwave energy, electromechanical, mechanicalforce, cooling, alternating or direct electrical current (DC current),chemical, electrochemical, or others. In some embodiments, the nasalseptum, nasal valve, and/or surrounding tissues may be strengthenedthrough the application of cryogenic therapy, or through the injectionor application of bulking agents, glues, polymers, collagen and/or otherallogenic or autogenic tissues, or growth agents.

Any one or more of the above energy-application mechanisms may also beused to reshape, remodel, or change mechanical or physiologic propertiesof structures of a nasal septum or surrounding tissues. For example, insome embodiments, energy may be applied to a targeted region of tissuesuch that the tissue modification results in a tightening, shrinking orenlarging of such targeted tissues resulting in a change of shape. Insome such embodiments, reshaping of a nasal septum section may beachieved by applying energy without necessarily applying a mechanicalreshaping force. For example energy can be used to selectively shrinktissue in specific locations of the nasal airway that will lead to acontrolled conformational change.

In some embodiments, strengthening and/or conformation change (i.e.,reshaping) of nasal septum tissue to reduce negative pressure duringinspiration may include modification of tissue growth and/or the healingand fibrogenic process. For example, in some embodiments energy may beapplied to a targeted tissue in the region of the nasal septum in such away that the healing process causes a change to the shape of the nasalseptum and/or a change in the structural properties of the tissue. Insome embodiments, such targeted energy application and subsequenthealing may be further controlled through the use of temporary implantsor reshaping devices (e.g., internal stents or molds, or externaladhesive strips).

In some embodiments, energy may be delivered into the cartilage tissueto cause a conformational change and/or a change in the physicalproperties of the cartilage. Energy delivery may be accomplished bytransferring the energy through the tissue covering the cartilage suchas the epithelium, mucosa, sub-mucosa, muscle, ligaments, tendon and/orskin. In some embodiments, energy may also be delivered to the cartilageusing needles, probes or microneedles that pass through the epithelium,mucosa, submucosa, muscle, ligaments, tendon and/or skin (as illustratedfor example in FIG. 4D).

In some embodiments, energy may be delivered into the submucosal tissueto cause a conformational change and/or a change in the physicalproperties of the submucosal tissue. Energy delivery may be accomplishedby transferring the energy through the tissue covering the submucosasuch as the epithelium, mucosa, muscle, ligaments, cartilage, tendonand/or skin. In some embodiments, energy may also be delivered to thesubmucosa using needles, probes, microneedles, micro blades, or othernon-round needles that pass through the epithelium, mucosa, muscle,ligaments, tendon and/or skin.

FIG. 3 illustrates an embodiment of a nasal septum treatment device 30.The device 30 comprises a treatment element 32 which may be configuredto be placed inside the nasal cavity, nasal passage, and/or nasal airwayto deliver the desired treatment. In some embodiments, the device 30 mayfurther comprise a handle section 34 which may be sized and configuredfor easy handheld operation by a clinician. In some embodiments, adisplay 36 may be provided for displaying information to a clinicianduring treatment.

In some embodiments, the information provided on the display 36 mayinclude treatment delivery information (e.g. quantitative informationdescribing the energy being delivered to the treatment element) and/orfeedback information from sensors within the device and/or within thetreatment element. In some embodiments, the display may provideinformation on physician selected parameters of treatment, includingtime, power level, temperature, electric impedance, electric current,depth of treatment and/or other selectable parameters.

In some embodiments, the handle section 34 may also comprise inputcontrols 38, such as buttons, knobs, dials, touchpad, joystick, etc. Insome embodiments, controls may be incorporated into the display, such asby the use of a touch screen. In further embodiments, controls may belocated on an auxiliary device which may be configured to communicatewith the treatment device 30 via analog or digital signals sent over acable 40 or wirelessly, such as via BLUETOOTH, WI-FI (or other 802.11standard wireless protocol), infrared or any other wired or wirelesscommunication method.

In some embodiments the treatment system may comprise an electroniccontrol system 42 configured to control the timing, location, intensityand/or other properties and characteristics of energy or other treatmentapplied to targeted regions of a nasal passageway. In some embodiments,a control system 42 may be integrally incorporated into the handlesection 34. Alternatively, the control system 42 may be located in anexternal device which may be configured to communicate with electronicswithin the handle section 34. A control system may include a closed-loopcontrol system having any number of sensors, such as thermocouples,electric resistance or impedance sensors, ultrasound transducers, or anyother sensors configured to detect treatment variables or other controlparameters.

The treatment system may also comprise a power supply 44. In someembodiments, a power supply may be integrally incorporated within thehandle section 34. In alternative embodiments, a power supply 44 may beexternal to the handle section 34. An external power supply 44 may beconfigured to deliver power to the handle section 34 and/or thetreatment element 32 by a cable or other suitable connection. In someembodiments, a power supply 44 may include a battery or other electricalenergy storage or energy generation device. In other embodiments, apower supply may be configured to draw electrical power from a standardwall outlet. In some embodiments, a power supply 44 may also include asystem configured for driving a specific energy delivery technology inthe treatment element 32. For example, the power supply 44 may beconfigured to deliver a radio frequency alternating current signal to anRF energy delivery element. Alternatively, the power supply may beconfigured to deliver a signal suitable for delivering ultrasound ormicrowave energy via suitable transducers. In further alternativeembodiments, the power supply 44 may be configured to deliver ahigh-temperature or low-temperature fluid (e.g. air, water, steam,saline, or other gas or liquid) to the treatment element 32 by way of afluid conduit.

In some embodiments, the treatment element 32 may have a substantiallyrigid or minimally elastic shape sized and shaped such that itsubstantially conforms to an ideal shape and size of a patient's nasalpassageway, including the nasal septum. In some embodiments, thetreatment element 32 may have a curved shape, either concave or convexwith respect to the interior of the lateral wall of the nasal passage.In some embodiments, the shape of a fixed-shape treatment element may besubstantially in a shape to be imparted to the cartilage or otherstructures of the nasal septum area.

In some embodiments, the treatment element 32 and control system 42 maybe configured to modify the properties of cartilage and/or createspecific localized tissue damage or ablation without the application ofenergy. For example, the treatment element 32 may be configured to apply(e.g., inject) a solution that modifies the properties of cartilage(e.g., collagenase, hyaluronidase, tosyllysylchloromethane, trypsin,trypsin/EDTA, and/or combinations thereof) at or near the tissue to betreated. In one embodiment, for example, the treatment element 32 mayinclude one or more needles to inject the solution (e.g., into the spacebetween the septal cartilage and the mucosal layer). In anotherembodiment, the treatment element 32 may be configured to chemicallycauterize tissue around a nasal septum by delivering a cauterizingsolution (e.g., silver nitrate, trichloroacetic acid, cantharidin, etc.)to the tissue. The treatment element 32 may include apertures configuredto permit the solution to pass through to the nose. In some embodiments,the treatment element 32 may aerosolize the solution. Other deliverymethods are also contemplated. The treatment element 32 may comprise alumen, through which the solution passes. The lumen may be fluidlyconnected to a reservoir or container holding the solution. The devicemay include an input control (e.g., a button or switch) configured tocontrol the delivery of the solution. In some embodiments, the treatmentelement 32 may include an applicator that can be coated in the solution(e.g., dipped in a reservoir of solution, swabbed with the solution,etc.) and the coated treatment element applicator may be applied totissue to be treated. In some embodiments, the treatment element may beconfigured to apply the solution to the patient over a prolonged periodof time (e.g., 30 seconds, 1 minute, 2 minutes, etc.).

In some embodiments, the treatment element 32 comprises shields or ringsconfigured to protect tissue surrounding the tissue to be treated fromcoming into contact with the solution. In some embodiments, a separateelement is used to shield tissue surrounding the tissue to be treatedfrom coming into contact with the solution. While such treatments may beperformed without the application of energy, in some embodiments, theymay be performed in conjunction with energy treatments. In oneembodiment, one or more shields may be configured to be placed on thenasal septum mucosa around the site of the deviation. In one embodiment,for example, there may be two rings—one for each side of the septum. Thedesign of the device may be “U” shaped to fit the two arms of deviceinto the two nostrils of the patient. The device may be spring loaded,such that when a user releases the device, the device is held in placeby its spring force.

In some embodiments, as shown for example in FIG. 3, the treatmentelement 32 may comprise a substantially cylindrical central portion witha semi-spherical or semi-ellipsoid or another shaped end-cap section atproximal and/or distal ends of the treatment element 32. In alternativeembodiments, the treatment element may comprise a substantiallyellipsoid shape as shown, for example in FIGS. 4A-4D. In someembodiments, an ellipsoid balloon as shown in FIG. 4A may have anasymmetrical shape. In alternative embodiments, the treatment element 32may have an asymmetrical “egg-shape” with a large-diameter proximal endand a smaller-diameter distal end. In some embodiments, the element 32can be shaped so as to impart a shape to the tissue treated that isconducive to optimal nasal airflow. Any suitable solid or expandablemedical balloon material and construction available to the skilledartisan may be used.

FIG. 4B illustrates an embodiment of a treatment element configured todeliver energy to an interior of a nose. In some embodiments, thetreatment element of FIG. 4B also includes an expandable balloon.

FIG. 4C illustrates an embodiment of a bifurcated treatment element 70having a pair of semi-ellipsoid elements 72, 74 sized and configured tobe inserted into the nose with one element 72, 74 on either side of theseptum. The elements may each have a medial surface 75 a & 75 b whichmay be substantially flat, curved or otherwise shaped and configured tolie adjacent to (and possibly in contact with) the nasal septum. In someembodiments, the elements 72, 74 may include expandable balloons withindependent inflation lumens 76, 78. In alternative embodiments, theelements 72, 74 have substantially fixed non-expandable shapes. In stillfurther embodiments, the elements 72, 74 may include substantiallyself-expandable sections. In some embodiments, the bifurcated treatmentelement halves 72, 74 may also carry energy delivery structures asdescribed elsewhere herein. In some embodiments, the shape of theelements 72, 74 may be modified by the operator to impart an optimalconfiguration to the treated tissue. The shape modification of elements72, 74 can be accomplished pre-procedure or during the procedure and canbe either fixed after modification or capable of continuousmodification.

In some embodiments, a nasal septum treatment system may also comprise areshaping device configured to mechanically alter a shape of soft tissueand/or cartilage in a region of the nasal septum in order to impart adesired shape and mechanical properties to the tissue of the walls ofthe nasal airway. In some embodiments the reshaping device may beconfigured to reshape the nasal septum and/or nasal valve into a shapethat improves the patency of one or both nasal valve sections at restand during inspiration and/or expiration. In some embodiments, thereshaping device may comprise balloons, stents, mechanical devices,molds, external nasal strips, spreader forceps or any other suitablestructure. In some embodiments, a reshaping device may be integrallyformed with the treatment element 32. In alternative embodiments, areshaping device may be provided as a separate device that may be usedindependently of the treatment element 32. As described in more detailbelow, such reshaping may be performed before, during or after treatmentof the nose tissue with energy, injectable compositions or cryo-therapy.

With reference to FIGS. 4A-4C, some embodiments of treatment elements 32may comprise one or more inflatable or expandable sections configured toexpand from a collapsed configuration for insertion into the nasalpassageway, to an expanded configuration in which some portion of thetreatment element 32 contacts and engages an internal surface of a nasalpassageway. In some embodiments, an expandable treatment element maycomprise an inflation lumen configured to facilitate injection of aninflation medium into an expandable portion of the treatment element. Inalternative embodiments, an expandable treatment element may compriseone or more segments comprising a shape-memory alloy material which maybe configured to expand to a desired size and shape in response to achange of temperature past a transition temperature. In someembodiments, such a temperature change may be brought about byactivating an energy-delivery (or removal) element in the treatmentelement 32.

In some embodiments, the treatment element 32 may expand with variouslocations on the element expanding to different configurations or notexpanding at all to achieve a desired shape of the treatment element. Insome embodiments, such expandable treatment elements or sections may beelastic, inelastic, or preshaped. In some embodiments, expandabletreatment elements or sections thereof may be made from shape-memorymetals such as nickel-cobalt or nickel-titanium, shape memory polymers,biodegradable polymers or other metals or polymers. Expandable balloonelements may be made of any elastic or inelastic expandable balloonmaterial.

In alternative embodiments, the treatment element 32 can act to changethe properties of the internal soft tissue of the nasal airway inconjunction with an external treatment device of fixed or variable shapeto provide additional force to change the shape of the nasal septum. Insome embodiments, an external mold element can be combined with aninternal element.

FIGS. 5A and 5B illustrate reshaping treatment devices 80 and 90,respectively. The treatment devices 80 and 90 are structured as clampdevices configured to engage a targeted section of the nasal airway witheither a clamping force or a spreading force. In some embodiments, thetreatment devices of FIGS. 5A and 5B may include energy deliveryelements (of any type described herein) which may be powered by a fluidlumen or cable 86.

The treatment device of FIG. 5A includes an outer clamp member 82 and aninner clamp member 84 joined at a hinge point 85. In some embodiments,the outer clamp member 82 may include an outwardly-bent section 83 sizedand configured to extend around the bulk of a patient's nose when theinner clamp member may be positioned inside the patient's nose. Theinner and outer tissue-engaging tips at the distal ends of the inner andouter clamp members may be configured to impart a desired shape to thenasal septum. In some embodiments, the tissue-engaging tips may beremovable to allow for sterilization and/or to allow for tips of a widerange of shapes and sizes to be used with a single clamp handle.

The treatment device of FIG. 5B includes an outer clamp member 92 and aninner clamp member 94 joined at a hinge point 95. The inner and outertissue-engaging tips at the distal ends of the inner and outer clampmembers may be configured to impart a desired shape to the nasalcartilage. In the illustrated embodiment, the outer clamp member 92includes a concave inner surface, and the inner clamp member includes amating convex inner surface. The shape and dimensions of the matingsurfaces may be designed to impart a desired shape to the structures ofa patient's nose. In some embodiments, the shape of the mating surfacesmay be modified by the operator to impart an optimal configuration tothe treated tissue. The shape modification of the mating surfaces can beaccomplished pre-procedure or during the procedure and can be eitherfixed after modification or capable of continuous modification.

In some embodiments, the tissue-engaging tips may be removable to allowfor sterilization and/or to allow for tips of a wide range of shapes andsizes to be used with a single clamp handle.

In alternative embodiments, the devices of FIGS. 5A and 5B may be usedas spreader devices by placing both clamp tips in a nasal passage andseparating the handles, thereby separating the distal tips. Inalternative embodiments, the handles may be configured to expand inresponse to a squeezing force. The shapes of the distal tips may bedesigned to impart a desired shape when used as a spreading device.

The reshaping elements of FIGS. 3-5B are generally configured to be usedonce and removed from a patient's nose once a treatment is delivered. Insome embodiments, treatments may further involve placing longer termtreatment elements, such as stents, molds, external strips, etc. for aperiod of time after treatment. An example of such a stent placed withina patient's nose after treatment is shown in FIG. 6. In someembodiments, the stent may be configured to be removed after atherapeutically effective period of time following the treatment. Insome embodiments, such a therapeutically effective period of time may beon the order of days, weeks or more.

In some embodiments, the treatment element 32 may be configured todeliver heat energy to the nasal septum. In such embodiments, thetreatment element may comprise any suitable heating element available tothe skilled artisan. For example, the treatment element 32 may compriseelectrical resistance heating elements. In alternative embodiments, theheating element may comprise conduits for delivering high-temperaturefluids (e.g. hot water or steam) onto the nasal tissue. In someembodiments, a high-temperature fluid heating element may comprise flowchannels which place high-temperature fluids into conductive contactwith nasal tissues (e.g. through a membrane wall) without injecting suchfluids into the patients nose. In further embodiments, any othersuitable heating element may be provided. In further embodiments, thetreatment element 32 may comprise elements for delivering energy inother forms such as light, laser, RF, microwave, cryogenic cooling, DCcurrent and/or ultrasound in addition to or in place of heatingelements.

U.S. Pat. No. 6,551,310 describes embodiments of endoscopic treatmentdevices configured to ablate tissue at a controlled depth from within abody lumen by applying radio frequency spectrum energy, non-ionizingultraviolet radiation, warm fluid or microwave radiation. U.S. Pat. No.6,451,013 and related applications referenced therein describe devicesfor ablating tissue at a targeted depth from within a body lumen.Embodiments of laser-treatment elements are described for example inU.S. Pat. No. 4,887,605, among others. U.S. Pat. No. 6,589,235 teachesmethods and device for cartilage reshaping by radiofrequency heating.U.S. Pat. No. 7,416,550 also teaches methods and devices for controllingand monitoring shape change in tissues, such as cartilage. The devicesdescribed in these and other patents and publications available to theskilled artisan may be adapted for use in treating portions of a nasalseptum or adjacent tissue as described herein. U.S. Pat. Nos. 7,416,550,6,589,235, 6,551,310, 6,451,013 and 4,887,605 are hereby incorporated byreference in their entireties for any and all purposes.

In alternative embodiments, similar effects can be achieved through theuse of energy removal devices, such as cryogenic therapies configured totransfer heat energy out of selected tissues, thereby lowering thetemperature of targeted tissues until a desired level of tissuemodification is achieved. Examples of suitable cryogenic therapydelivery elements are shown and described for example in U.S. Pat. Nos.6,383,181 and 5,846,235, the entirety of each of which is herebyincorporated by reference for any and all purposes.

In some embodiments, the treatment element 32 may be configured todeliver energy (e.g. heat, RF, ultrasound, microwave) or cryo-therapyuniformly over an entire outer surface of the treatment element 32,thereby treating all nasal tissues in contact with the treatment element32. Alternatively, the treatment element 32 may be configured to deliverenergy at only selective locations on the outer surface of the treatmentelement 32 in order to treat selected regions of nasal tissues. In suchembodiments, the treatment element 32 may be configured so that energybeing delivered to selected regions of the treatment element can beindividually controlled. In some embodiments, portions of the treatmentelement 32 are inert and do not deliver energy to the tissue. In furtheralternative embodiments, the treatment element 32 may be configured withenergy-delivery (or removal) elements distributed over an entire outersurface of the treatment element 32. The control system 42 may beconfigured to engage such distributed elements individually or inselected groups so as to treat only targeted areas of the nasalpassageway.

In some embodiments, the treatment element 32 may be a balloon withenergy delivery elements positioned at locations where energy transferis sufficient or optimal to effect change in breathing. Such a balloonmay be configured to deliver energy while the balloon is in an inflatedstate, thereby providing a dual effect of repositioning tissue anddelivering energy to effect a change the nasal septum. In otherembodiments, a balloon may also deliver heat by circulating a fluid ofelevated temperature though the balloon during treatment. The ballooncan also deliver cryotherapy (e.g., by circulating a low-temperatureliquid such as liquid nitrogen) while it is enlarged to increase thenasal valve diameter or otherwise alter the shape of a nasal septum.FIG. 7 illustrates an example of an energy-delivery balloon beinginserted into a patient's nose for treatment. Several embodiments may beemployed for delivering energy treatment over a desired target area. Forexample, in some embodiments, a laser treatment system may treat a largesurface area by scanning a desired treatment pattern over an area to betreated. In the case of microwave or ultrasound, suitably configuredtransducers may be positioned adjacent to a target area and desiredtransducer elements may be activated under suitable depth focus andpower controls to treat a desired tissue depth and region. In someembodiments, ultrasound and/or microwave treatment devices may also makeuse of lenses or other beam shaping of focusing devices or controls. Insome embodiments, one or more electrical resistance heating elements maybe positioned adjacent to a target region, and activated at a desiredpower level for a therapeutically effective duration. In someembodiments, such heating elements may be operated in a cyclical fashionto repeatedly heat and cool a target tissue. In other embodiments, RFelectrodes may be positioned adjacent to and in contact with a targetedtissue region. The RF electrodes may then be activated at some frequencyand power level therapeutically effective duration. In some embodiments,the depth of treatment may be controlled by controlling a spacingbetween electrodes. In alternative embodiments, RF electrodes mayinclude needles which may puncture a nasal septum tissue to a desireddepth (as shown for example in FIG. 4D and in other embodiments below).

In some embodiments, the treatment element 32 and control system 42 maybe configured to deliver treatment energy or cryotherapy to a selectedtissue depth in order to target treatment at specific tissues. Forexample, in some embodiments, treatments may be targeted at tighteningsections of the epithelium of the nasal septum. In other embodiments,treatments may be targeted at strengthening soft tissues underlying theepithelium. In further embodiments, treatments may be targeted atstrengthening cartilage in the area of the nasal valve and/or upperlateral cartilage. In still further embodiments, treatments may betargeted at stimulating or modifying the tissue of muscles of the noseor face in order to modify the nasal septum.

In some embodiments, the treatment element 32 and control system 42 maybe configured to deliver treatment energy to create specific localizedtissue damage or ablation, stimulating the body's healing response tocreate desired conformational or structural changes in the nasal tissue.

In some embodiments, a treatment element may be configured to treat apatient's nasal septum by applying treatment (e.g., energy, cryotherapy,or other treatments) from a position outside the patient's nose. Forexample, in some embodiments, the devices of FIGS. 5A and 5B may beconfigured to apply energy from an element positioned outside apatient's nose, such as on the skin. In another embodiment, a device maybe placed on the external surface of the nose that would pull skin toeffect a change in the nasal airway. Treatment may then be applied tothe internal or external nasal tissue to achieve a desired nasal septumconfiguration.

In some embodiments, the device is configured to position tissue to bereshaped. In some embodiments, the device comprises features andmechanisms to pull, push or position the nasal tissue into a mold forreshaping. For example, suction, counter traction, or compressionbetween two parts of the device may be used.

In some embodiments, the treatment device comprises one, two, three,four, or more molds configured to reshape tissue. The mold or reshapingelement may be fixed in size or may vary in size. The mold may also befixed in shape or may vary in shape. For example, the size or shape ofthe element may be varied or adjusted to better conform to a nasalseptum of a patient. Adjustability may be accomplished using a varietyof means, including, for example, mechanically moving the mold by way ofjoints, arms, guidewires, balloons, screws, stents, and scissoring arms,among other means. The mold may be adjusted manually or automatically.The mold is configured to impart a shape to the tissues of the nasalseptum area to improve airflow or perceived airflow.

In some embodiments, the mold or reshaping element comprises a separateor integrated energy delivery or treatment element (e.g., an electrodesuch as those described below with respect to FIGS. 8A-8J). Thetreatment element may be fixed or adjustable in size. For example, thetreatment element may be adjusted to better conform to the nasal septumof a patient. In the case of a separate reshaping element and treatmentelement, a distance between the two elements may either be fixed oradjustable. Adjustability may be accomplished using a variety of means,including, for example, mechanically moving the mold by way of joints,arms, guidewires, balloons, screws, stents, and scissoring arms, amongother means.

In some embodiments, the mold or another part of the device isconfigured to deliver cooling (discussed in more detail below). In someembodiments, the mold or reshaping element comprises a balloonconfigured to reshape and/or deform tissue. A balloon may also beconfigured to deliver energy such as heat using hot liquid or gas.

Examples of Various Electrode Arrangements

Described below are embodiments of various treatment devices and, moreparticularly, electrode arrangements that may be used for applyingenergy to tissue, such as hyaline cartilage of the nasal septum area.These electrodes may, for example, deliver RF energy to preferentiallyshape the tissue to provide improved nasal breathing. In someembodiments, one or more electrodes may be used alone or in combinationwith a tissue shaping device or mold. In other embodiments, one or moreelectrodes may be integrally formed with a tissue shaping device ormold, so that the electrodes themselves create the shape for the tissue.In some embodiments, the energy delivery devices may use alternatingcurrent. In some embodiments, the energy delivery devices may use directcurrent. In certain such embodiments, the energy delivery device maycomprise a configuration utilizing a grounding pad.

In some embodiments, the term “electrode” refers to any conductive orsemi-conductive element that may be used to treat the tissue. Thisincludes, but is not limited to metallic plates, needles, and variousintermediate shapes such as dimpled plates, rods, domed plates, etc.Electrodes may also be configured to provide tissue deformation inaddition to energy delivery. Unless specified otherwise, electrodesdescribed can be monopolar (e.g., used in conjunction with a groundingpad) or bipolar (e.g., alternate polarities within the electrode body,used in conjunction with other tissue-applied electrodes).

In some embodiments, “mold”, “tissue shaper”, “reshaping element” andthe like refer to any electrode or non-electrode surface or structureused to shape, configure or deflect tissue during treatment.

In some embodiments, “counter-traction” refers to applying a forceopposite the electrode's primary force on the tissue to increasestability, adjustability, or for creating a specific shape.

As shown in FIG. 8A, in some embodiments, bipolar electrodes may be usedto deliver energy, with one electrode 202 placed internally in the nose,for example against the nasal septum, and one electrode 204 placedexternally on the outside of the nose. This embodiment mayadvantageously provide direct current flow through the tissue with nophysical trauma from needles (as shown in some embodiments below). Asshown in FIG. 8B, in some embodiments, bipolar electrodes may be used todeliver energy, with both electrodes 210, 212 placed internally. Aninsulating spacer 214 may be placed between them. This embodiment may besimple and may advantageously minimize current flow through the skinlayer. In some embodiments, bipolar electrodes 220, 222 may be bothplaced externally and may be connected to a passive molding element 224placed inside the nasal septum adjacent to tissue to be treated, asshown in FIG. 8C. This embodiment may advantageously minimize thepotential for mucosal damage. In some embodiments, electrodes placedinternally may be shaped to function as a mold or may comprise anadditional structure that may function as a mold.

In some embodiments, a monopolar electrode may be used to deliverenergy. As shown in FIG. 8D, the electrode 230 may be placed internallyand may be connected to an external, remote grounding pad 232. Thegrounding pad 232 may, for example, be placed on the abdomen of apatient or in other desired locations. This embodiment mayadvantageously be simple to manufacture and may minimize current flowthrough the skin. In some embodiments, a monopolar electrode may beplaced externally and may be connected to a molding element placed atthe nasal septum as well as a remote grounding pad. This embodiment mayalso advantageously be simple to manufacture, may minimize mucosalcurrent flow, and may also be simple to position. In some embodiments,electrodes placed internally may be shaped to function as a mold or maycomprise an additional structure that may function as a mold.

In some embodiments, monopolar transmucosal needles may be used todeliver energy. The needle electrodes 240 may be placed internally, asshown in FIG. 8E penetrating through the mucosa to the cartilage, and aremote grounding pad 242 or element may be placed externally. In someembodiments, monopolar transmucosal needles may be used in conjunctionwith one or more molding elements which may be disposed on or around theneedles. In some embodiments, monopolar transdermal needles may be usedto deliver energy. In other embodiments (not shown), the needles may beplaced external to the nose, and penetrate through to tissue to betreated. Needle configurations may advantageously target the cartilagetissue to be treated specifically. The monopolar transdermal needles maybe used in conjunction with an internal molding device (not shown).

In some embodiments, bipolar transmucosal needles may be used to deliverenergy to tissue to be treated. The needles may be placed internally,with an insulating spacer between them and may penetrate through themucosa to the cartilage to be treated. In some embodiments, the bipolartransmucosal needles may be used in combination with one or moreinternal molding elements. The one or more molding elements may beplaced on or near the needles. In some embodiments, bipolar transdermalneedles may be used to deliver energy. In other embodiments, thetransdermal needles may be placed externally and penetrate through totissue to be treated. Needle configurations may advantageously targetthe cartilage tissue to be treated specifically. The transdermal bipolarneedles may be used in conjunction with an internal molding element.

As shown in FIG. 8F, in some embodiments, an array of electrodescomprising one, two, or many pairs of bipolar needles 252 are located ona treatment element configured to be placed into contact with thecartilage. An insulator 254 may be disposed between the bipolar needles252. An insulator may also be used on part of the needle's length toallow energy to be delivered only to certain tissue structures, such ascartilage. The electrodes may be placed either internally ortransmucosally or they may be placed externally or transdermally. In theembodiment illustrated in FIG. 8F, the insulator 254 may also functionas a mold or molding element. In other embodiments (not shown), thearray of electrodes is used in conjunction with a separate tissuereshaping element.

FIG. 8G illustrates another embodiment of a treatment element comprisesone, two or many pairs of bipolar electrodes 260. As opposed to FIG. 8F,where the pairs of electrodes are arranged side-by-side, the embodimentof FIG. 8G arranges the pairs of electrodes along the length of thetreatment element. The electrodes of FIG. 8G are also non-penetrating,in contrast to the needles of FIG. 8F. The electrodes 260 may be placedagainst either the skin, externally, or the mucosa, internally as ameans of delivering energy to target tissue such as cartilage.

In some embodiments of treatment devices comprising an array or multiplepairs of electrodes, each pair of electrodes (bipolar) or each electrode(monopolar) may have a separate, controlled electrical channel to allowfor different regions of the treatment element to be activatedseparately. For example, the needles or needle pairs of FIG. 8F may beindividually controlled to produce an optimal treatment effect. Foranother example, the separate electrodes of FIGS. 8B and 8C may beindividually controlled to produce an optimal treatment effect. Otherexamples are also contemplated. The channels may also comprise separateor integrated feedback. This may advantageously allow for more accuratetemperature control and more precise targeting of tissue. Separatecontrol may also allow energy to be focused and/or intensified on adesired region of the treatment element in cases where the anatomy ofthe nasal tissue/structures does not allow the entire electrode regionof the treatment element to engage the tissue. In such embodiments, thenasal tissue that is in contact with the treatment element may receivesufficient energy to treat the tissue.

Combinations of the described electrode configurations may also be usedto deliver energy to tissue to be treated (e.g., by being reshaped). Forexample, transmucosal needles 264 may be placed internally, penetratingthrough to the tissue to be treated, and an electrode 266 may be placedexternally or on an opposite side of the tissue to be treated, as shownin FIG. 8H. This embodiment may advantageously target the cartilagetissue specifically and be biased for mucosal preservation. For anotherexample, transdermal needles 268 may be inserted on an opposite side ofthe nasal septum from an electrode 270, as shown in FIG. 8I. Thisembodiment may advantageously target the cartilage tissue specificallyand be biased towards mucosal preservation. For another example bipolarneedle electrodes 272, 274 can be placed on both sides of tissue to betreated, as shown in FIG. 8J. This embodiment may advantageously targetthe cartilage tissue specifically. Some embodiments of treatmentelements may include inert areas which do not delivery energy to thetissue. Other combinations of electrode configuration are also possible.

Examples of Treatment Devices Including Electrodes

Embodiments of treatment devices incorporating treatment elements suchas the electrodes described above are illustrated in FIGS. 9A-21B. Theinstrument designs described in these embodiments may be used in adevice such as the device 30, described above, and in the system of FIG.3. In some embodiments, the devices provide tissue reshaping or moldingin addition to energy delivery. Applying energy to the nasal tissue mayrequire properly positioning the electrode(s) at the nasal septum,deflecting or deforming the tissue into a more functional shape, anddelivering or applying energy consistently prior to device removal.Embodiments described herein may advantageously provide adjustability,visualization of effect, ease of use, ease of manufacturability andcomponent cost. Molding and reshaping of the tissues of the nose mayallow for non-surgical nasal breathing improvement without the use ofimplants.

FIG. 9A depicts a device 300 comprising a single inter-nasal monopolarelectrode 301 located at the end of a shaft 302. The shaft is attachedto a handle 303. The electrode configuration may be similar to thatdescribed with respect to FIG. 8D. FIG. 9B depicts another device 304comprising a single inter-nasal, monopolar electrode 305. The electrode305 is located at the distal end of a shaft 306, which is attached to ahandle 307. The handle comprises a power button 308 that may be used toactivate and deactivate the electrode. As stated above, the device 304may either comprise a generator or be connected to a remote generator.The electrode 305 may be provided on an enlarged, distal end of theshaft 306, and in the embodiment illustrated has a convex shapeconfigured to press against and create a concavity in the nasalcartilage.

FIG. 10A depicts a side view of a device 310 comprising a singleinter-nasal electrode 312 located at the end of a shaft 314. The shaftis attached to a handle 316. An external mold 318 is attached to thehandle 316 and can be moved relative to the electrode shaft 314. Theexternal mold 318 has a curved shape with an inner concave surface thatmay be moved in order to press against an external surface of apatient's nose to compress tissue between the external mold 318 and theelectrode 312. FIG. 10B provides a front view of the device 310.

FIG. 11A depicts a device 320 comprising a single inter-nasal electrode322 attached to the end of a shaft 324. The shaft 324 is attached to ahandle 326. An internal shaft 328 comprising a tissue-contacting surfaceis attached to the handle 326. The internal shaft 328 can be movedrelative to the electrode shaft 324 and may provide counter-tractionand/or positioning. For example, when the electrode 322 is placedagainst a patient's nasal septum, the counter-traction element 328 maybe pressed against the patient's upper or lower lateral cartilage.

FIG. 11B depicts a device 450 similar to device 320 of FIG. 11Acomprising an inter-nasal electrode 451 located at a distal end of ashaft 452 connected to a handle 454. The device 450 further comprises acounter-traction element 456 connected to a handle 458. Like the device320 depicted in FIG. 11A, the connection 460 between the two handles454, 458 is such that squeezing the two handles 454, 458 together causesthe electrode 451 and the counter-traction element 456 to move away fromeach other, spreading the tissue they are contacting.

FIG. 12A depicts a device 330 comprising a single inter-nasal electrode332 located at the end of a shaft 334. The shaft 334 is attached to ahandle 336. The device 330 comprises another single inter-nasalelectrode 338 attached to the end of a shaft 340. The shaft 340 isattached to a handle 342. The device comprises a connection 344 betweenthe two handles 336, 342 that allows simultaneous deformation andtreatment of both nostrils.

FIG. 12B depicts a device 470 similar to device 330 of FIG. 12Acomprising a first inter-nasal electrode 472 located at a distal end ofa shaft 474 connected to a handle 476. The device 470 comprises a secondinter-nasal electrode 478 located at a distal end of a second shaft 480connected to a second handle 482. The connection 484 between the twohandles 476, 482 is such that squeezing the handles 476, 482 togethercauses the electrodes 472, 478 to move together, compressing tissuetherebetween. The device 470 comprises a ratcheting mechanism 475between the two handles 476, 482 that allows the relative positions ofthe electrodes 472, 478 to be locked during treatment.

FIG. 13A depicts a side view of a device 350 also used for treating twonostrils comprising an inter-nasal electrode 352 attached to the end ofa shaft 354. The shaft 354 is attached to a handle 356. As seen in thefront view provided in FIG. 13B, the device 350 comprises a secondinter-nasal electrode 358. The second inter-nasal electrode 358 isattached to the end of a shaft which is attached to a handle. Aconnection between the two handles allows simultaneous deformation andtreatment of the nostrils. An external mold 366 is attached to thehandles. The mold 366 may be moved relative to the electrode shafts 354,360 and may provide counter-traction (e.g., against the bridge of thenose) and positioning.

FIGS. 13C-E depicts a device 490 similar to the device 350 shown in FIG.13A and FIG. 13B. FIGS. 13C and 13D depict side and top views of adevice 490 comprising a handle 492. The handle 492 bifurcates into afirst shaft 494 with a first inter-nasal electrode 496 located at adistal end of the shaft 494 and a second shaft 498 with a secondinter-nasal electrode 500 located at a distal end of the shaft 498. Thedevice 490 comprises a mold 502 configured to provide counter-tractionor compression of the bridge of the nose. The mold 502 comprises ahandle 504. The connection 506 between the handles 492, 504 is such thatsqueezing the two handles 492, 504 causes the electrodes 496, 500 andthe mold 502 to be compressed together. FIG. 13E depicts the device 490being used on a patient. The arrows indicate the directions in which thehandles 492, 504 are configured to be squeezed.

FIG. 14A depicts a front view of a device 370 comprising an inter-nasalelectrode 372 attached to the end of a shaft 374 (shown in top view ofFIG. 14B). The shaft 374 is attached to a handle 376. The device 370comprises a second inter-nasal electrode 378 attached to the end of asecond shaft 380. The second shaft 380 is attached to a second handle382. A connection 384 between the two handles 376, 382 may allowsimultaneous deformation and treatment of the nostrils. External molds386, 388 are attached to the handles and can be moved relative to eachelectrode shaft 374, 380. The molds 386, 388 may providecounter-traction, compression of tissue, positioning, and externaltissue deformation.

FIG. 15A depicts a front view of device 390 comprising a firstinter-nasal electrode 392 and a second inter-nasal electrode 398. Asshown in the side view of FIG. 15B, the device 390 comprises a firstinter-nasal electrode 392 attached to the end of a shaft 394. The shaftis attached to a handle 396. A second inter-nasal electrode 398 isattached to the end of a second shaft 400, as shown in the top view ofFIG. 15C. The second shaft 400 is attached to a second handle 402. Aconnection 404 between the two handles 396, 402 may allow simultaneousdeformation and treatment of the nostrils. Additional internal shafts406, 408 comprise tissue-contacting surfaces and are attached to thehandles 396,402. The internal shafts 406, 408 may be moved relative toeach electrode shaft 394, 400 (shown in FIG. 15B) and may providecounter-traction and positioning.

FIG. 16 depicts a system 410 comprising a first device having anextra-nasal electrode 412 along a concave surface configured to bepositioned against an external surface of a patient's nose, theelectrode 412 being attached to the end of a shaft 414. The shaft 414 isattached to a handle 416. A separate device 417 comprising an internaltissue mold 418 is attached to a shaft 420. The internal tissue mold isconfigured to be positioned inside the patient's nose. The shaft 420 isattached to a handle 422. Each handle 422, 416 may be manipulatedindividually and may apply energy and deformation to create a desiredtissue effect.

FIG. 17A depicts a side view of a device 430 comprising an extra-nasalelectrode 431 attached to the end of a shaft 432. The shaft 432 isattached to a handle 434. The device 430 also comprises an internaltissue mold 436 attached to a shaft 438 which is attached to a handle440. The handles 434, 440 are attached together and may be movedrelative to each other to simultaneously deliver energy and deformtissue. FIG. 17B depicts a front view of the device 430.

FIG. 18 depicts a device 390 comprising pairs of bipolar electrodes 392located at the distal end of a shaft 394. The electrodes may be similarto the electrodes described with respect to the electrode configurationof FIG. 8G in that they are non-penetrating. The shaft 394 is connectedto a handle 398 which comprises a button 395 configured to activate anddeactivate the electrodes. As stated above, the device 390 may eithercomprise a generator or be connected to a remote generator.

FIG. 19A depicts the treatment element 503 of a treatment device (e.g.,device 30). The treatment element 503 of the device comprises amonopolar electrode 505. A cross-section of the treatment element 503 isshown in FIG. 19B. It comprises an asymmetrical shape and has a convexsurface where the electrode is positioned configured to conform to onlyone of a patient's nostrils (for example, a patient's right nostril).More specifically, the convex surface is configured such that wheninserted into the particular nostril, the convex surface would belocated adjacent the nasal septum. The treatment element 503 furthercomprises a light 507 configured to illuminate the treatment area. Forexample an LED or a visible laser may be used. The visible laser mayexperience less diffusion in the tissue. Furthermore, the light 507 canbe situated such that light can be transmitted through the nasal tissue(including the skin) and can be visualized externally by the user. Theuser can then use the light to properly position the device in thedesired location. Because the electrode 505 is not centered on thetreatment element 503 of the device, a separate device having amirror-image configuration may be required to treat the other nostril.

FIG. 20A depicts the treatment element 512 of a treatment device (e.g.,device 30). The treatment element 512 of the device comprises twomonopolar electrodes 514, 516 provided side-by-side on a convex surfaceof the treatment element. The cross section of the treatment element512, shown in FIG. 20B, is configured to conform to the shape eithernostril, depending on which side of the device (and accordingly, whichof electrode 514 or 516) is placed in contact with the patient's nasalseptum. Monopolar electrodes 514, 516 may allow the same treatmentelement 512 to be used for treatment in both nostrils, and eachelectrode may be activated separately depending on which side needs tobe used. The treatment element 512 also comprises two lights 518, 520(e.g., LEDs, lasers) configured to illuminate the treatment area forboth nostrils. One or both of the lights 518, 520 can also be situatedsuch that light can be transmitted through the nasal tissue (includingthe skin) and can be visualized externally by the user. The user canthen use the light to properly position the device in the desiredlocation.

FIG. 21A depicts a treatment element 522 of a treatment device (e.g.,device 30). The tip 522 of the device comprises a monopolar electrode524. The tip 522 comprises a symmetrical cross-section as shown in FIG.21B. The tip 522 comprises a light 526 (e.g., LED) configured toilluminate the treatment area. The light 526 can also be situated suchthat light can be transmitted through the nasal tissue (including theskin) and can be visualized externally by the user. The symmetrical tipallows the user to treat either left or right nostril. The user can thenuse the light to properly position the device in the desired location.

FIGS. 22A-G depict a treatment device 530 similar to the embodiments ofFIGS. 8D, 9A, and 9B. FIGS. 22A and 22F provide perspective views of thedevice 530. The device 530 comprises a treatment element 532 at itsdistal tip 534. The treatment element 532 comprises an electrode 535.The body of the treatment element 532, itself, may comprise aninsulating material. The treatment element 532 may be provided on anenlarged distal tip 534 of an elongate shaft 536, and as in theembodiment illustrated, may have a convex shape configured to pressagainst and create a concavity in the nasal cartilage (e.g., in thecartilage of the nasal septum). The distal tip 534 is located at thedistal end of shaft 536. The shaft is attached at its proximal end to ahandle 538. The handle 538 comprises an input control such as a powerbutton 540 on its front side that may be used to activate and deactivatethe electrode. The power button 540 may be positioned in a recess of thehandle to allow for finger stability when activating and deactivatingthe electrode. In other embodiments, the input control is in the form ofa switch or dial. Other configurations are also possible as describedabove.

The device 530 comprises a flexible wire or cable 542 electricallyconnected to an adaptor 544. The adaptor 544 can be used to connect thedevice 530 to a remote generator (not shown). The adaptor 544 may allowtransmission of treatment energy between a remote generator and thedevice 530. The adaptor may also allow transmission of any sensorsignals between the device 530 and a generator or control unit. Thedevice 530 may either comprise an integrated generator or be connectedto a remote generator. The treatment device 530 may be provided in asystem or kit also including the remote generator. The system or kit(with or without the remote generator) may also include a groundingdevice and/or a cooling device as described above and further below. Insome embodiments, the kit includes a positioning element (e.g., a“cottle” device) configured to help a user locate the optimal treatmentarea.

FIGS. 22B and 22C depict front and back views of the device. As shown inFIGS. 22B and 22C, the handle 538 of the device generally as a roundedelongate shape. Other shapes are also possible. For example the device530 may have a square shaped cross section. In some embodiments, acircumference (or width or cross-sectional area) of the handle 538 mayincrease distally along the length of the handle 538.

FIGS. 22D and 22E depict side views of the device. As shown in FIGS. 22Dand 22E, the handle 538 of the device 530 may comprise an indentation orrecess around the middle of the handle 538. This may allow for enhancedgrip and control when a user is holding the device. The indentation orrecess may be near the input control or power button 540 to allow a userto easily activate and deactivate the device while holding it in acomfortable position.

In some embodiments, the shaft has a width or diameter of about 0.125inches to about 0.25 inches. In some embodiments, the shaft is about 1.5inches to about 4 inches long. In some embodiments, the shaft comprisesa polymer such as polycarbonate or PEEK. In other embodiments, the shaftcomprises stainless steel or other metals. The metals may be coated withan external and/or internal insulating coating (e.g., polyester,polyolefin, etc.). The handle may comprise the same material as theshaft, in some embodiments. In some embodiments, the shaft is rigid.This may allow a user of the device increased control over thedeformation of nasal tissue. In some embodiments, the shaft comprisessome amount of flexibility. This flexibility may allow a user adjust anangle of the distal tip by bending the distal end of the shaft.

FIG. 22G depicts a larger view of the distal tip 534 of the device 530.As shown best in FIG. 22G, the treatment element 532 comprises agenerally elongate shape. The front of the treatment element 532comprises a shallow, curved surface, providing a convex shape configuredto deform the nasal tissue and create a concavity therein. In someembodiments, the front of the treatment element comprises a concaveshape. The shape of the front surface of the treatment element may beselected to conform to the nasal tissue. The back of the treatmentelement 532 also comprises a shallow curved surface. As best seen inFIGS. 22D and 22E, the back surface varies in width along the length ofthe back surface of the treatment element 532. The back surface widens,moving distally along the tip until it is nearly in line with theproximal end of the electrode plate 535. The back surface then narrowstowards the distal tip of the treatment element 532. This shape maymaximize visualization of the area to be treated, while, at the sametime, providing sufficient rigidity for treatment. Other shapes are alsopossible. For example, the treatment element may comprise a generallyspherical or cylindrical shape. In some embodiments, the treatmentelement comprises an angular shape (e.g., triangular, conical) which mayallow for close conformation to the tissue structures. The treatmentelement 532 comprises a monopolar electrode plate 535. The monopolarelectrode plate 535 can be in the shape of a rectangle having a curvedor convex tissue-facing surface. Other shapes are also possible (e.g.,square, circular, ovular, etc.). The electrode 535 may protrude slightlyfrom the treatment element 532. This may allow the electrode to itselfprovide a convex shape configured to create a concavity in tissue to betreated.

In some embodiments, the treatment element has a width or diameter ofabout 0.25 inches to about 0.45 inches. In some embodiments, thetreatment element is about 0.4 inches to about 0.5 inches long. Thetreatment element can, in some embodiments, comprise a ceramic material(e.g., zirconium, alumina, silicon glass). Such ceramics mayadvantageously possess high dielectric strength and high temperatureresistance. In some embodiments, the treatment element comprisespolyimides or polyamides which may advantageously possess gooddielectric strength and elasticity and be easy to manufacture. In someembodiments, the treatment element comprises thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the treatment elementcomprises thermoset polymers, which may advantageously provide gooddielectric strength and good elasticity. In some embodiments, thetreatment element comprises glass or ceramic infused polymers. Suchpolymers may advantageously provide good strength, good elasticity, andgood dielectric strength.

In some embodiments, the electrode has a width of about 0.15 inches toabout 0.25 inches. In some embodiments, the electrode is about 0.2inches to about 0.5 inches long. In some embodiments, the treatmentelement comprises steel (e.g., stainless, carbon, alloy). Steel mayadvantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein comprise materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein compriseanodized aluminum. Anodized aluminum may advantageously be highly stiffand low in cost. In some embodiments, the electrodes or energy deliveryelements described herein comprise titanium which may advantageouslypossess a high strength to weight ratio and be highly biocompatible. Insome embodiments, the electrodes or energy delivery elements describedherein comprise nickel titanium alloys. These alloys may advantageouslyprovide high elasticity and be biocompatible. Other similar materialsare also possible.

As shown in the embodiment of FIG. 22G, the treatment element 532further comprises a pin-shaped structure comprising a thermocouple 533within an insulating bushing extending through a middle portion of theplate 532. In some embodiments, different heat sensors (e.g.,thermistors) may be used. In some embodiments, the thermocouple 533 isconfigured to measure a temperature of the surface or subsurface oftissue to be treated or tissue near the tissue to be treated. Apin-shape having a sharp point may allow the structure to penetrate thetissue to obtain temperature readings from below the surface. Thethermocouple can also be configured to measure a temperature of thetreatment element 532 itself. The temperature measurements taken by thethermocouple can be routed as feedback signals to a control unit (e.g.,the control system 42 described with respect to FIG. 3) and the controlunit can use the temperature measurements to adjust the intensity ofenergy being delivered through the electrode. In some embodiments,thermocouples or other sensing devices may be used to measure multipletissue and device parameters. For example, multiple thermocouples orthermistors may be used to measure a temperature at different locationsalong the treatment element. In some embodiments, one of the sensors maybe configured to penetrate deeper into the tissue to take a measurementof a more interior section of tissue. For example, a device may havemultiple sensors configured to measure a temperature at the mucosa, thecartilage, and/or the treatment element itself. As described above, insome embodiments, the sensors described herein are configured to take ameasurement of a different parameter. For example, tissue impedance canbe measured. These measurements can be used to adjust the intensityand/or duration of energy being delivered through the treatment element.This type of feedback may be useful from both an efficacy and a safetyperspective.

As shown in FIG. 22G, in some embodiments the thermocouple is within apin shaped protrusion on the surface of the electrode 532. In otherembodiments, the thermocouple can simply be on the surface of theelectrode. In other embodiments, the thermocouple can protrude from thesurface of the electrode in a rounded fashion. Rounded structures may bepressed into the tissue to obtain subsurface temperature readings. Otherconfigurations and locations for the thermocouple are also possible. Theuse of thermocouples or temperature sensors may be applied not only tothe embodiment of FIG. 22G, but also to any of the other embodimentsdescribed herein.

FIGS. 23A-G depict a treatment device 550 similar to the embodiments ofFIGS. 8F and 18. FIGS. 23A and 23F are perspective views of the device550 and show the device 550 comprising a treatment element 552 at thedistal tip 556 of the device 550. The treatment element 552 may beprovided on an enlarged distal tip 556 of an elongate shaft 558, and asin the embodiment illustrated, may have a convex shape configured topress against and create a concavity in the nasal cartilage (e.g., incartilage of the nasal septum). The distal tip 556 is located at adistal end of shaft 558. The shaft is attached at its proximal end to ahandle 560. The handle 560 comprises an input control, such as a powerbutton 562, on its front side that may be used to activate anddeactivate the electrode. The power button may be positioned in a recessof the handle to allow for finger stability when activating anddeactivating the electrode. In other embodiments, the input control isin the form of a switch or dial. Other configurations are also possibleas described above. The device 550 may either comprise a generator or beconnected to a remote generator. The device 550 may comprise a flexiblewire or cable 564 that connects to an adaptor 566 that is configured tobe plugged into a remote generator (not shown). The adaptor 566 mayallow transmission of treatment energy between a remote generator andthe device 550. The adaptor 566 may also allow transmission of anysensor signals between the device 550 and a generator or control unit.The treatment device 550 may be provided in a system or kit alsoincluding the remote generator. The system or kit (with or without theremote generator) may also include a grounding device and/or a coolingdevice as described above and further below. In some embodiments, thekit includes a positioning element (e.g., a “cottle” device) configuredto help a user locate the optimal treatment area.

In some embodiments, the shaft has a width or diameter or about 0.235inches to about 0.25 inches. In some embodiments, the shaft is about 1.5inches to about 4 inches long. In some embodiments, the shaft and/orhandle comprises a polymer such as polycarbonate or PEEK. In otherembodiments, the shaft comprises stainless steel or other metals. Themetals may be coated with an external and/or internal insulating coating(e.g., polyester, polyolefin, etc.). The handle may comprise the samematerial as the shaft, in some embodiments. In some embodiments, theshaft is rigid. This may allow a user of the device increased controlover the deformation of nasal tissue. In some embodiments, the shaftcomprises some amount of flexibility. This flexibility may allow a useradjust an angle of the distal tip by bending the distal end of theshaft.

FIGS. 23B and 23C depict side views of the device. As shown in FIGS. 23Band 23C, the handle 560 of the device 550 may comprise an indentation orrecess around the middle of the handle 560. This may allow for enhancedgrip and control when a user is holding the device. The indentation orrecess may be near the input control or power button 562 to allow a userto easily activate and deactivate the device while holding it in acomfortable position.

FIGS. 23D and 23E depict front and back views of the device. As shown inFIGS. 23D and 23E, the handle 560 of the device generally comprises arounded elongate shape. Other shapes are also possible. For example thedevice 550 may have a square shaped cross section. In some embodiments,a circumference (or width or cross-sectional area) of the handle 560 mayincrease distally along the length of the handle 560.

FIG. 23G depicts a larger view of the distal tip 556 of the device 550.As shown best in FIG. 23G, the treatment element 552 comprises agenerally elongate shape. The front of the treatment element 552comprises a shallow curved surface, providing a convex shape configuredto deform the nasal tissue and create a concavity therein. In someembodiments, the front of the treatment element comprises a concaveshape. The shape of the front surface of the treatment element may beselected to conform to the nasal tissue. The back surface of thetreatment element 552 comprises a shallow curved surface along most ofits length. As best seen in FIGS. 23B and 23C, the back surface narrowsdistally along the length of the element 552 from approximately thedistal end of the needle electrodes to the distal tip of the treatmentelement 552. This shape may maximize visualization of the area to betreated, while, at the same time, providing sufficient rigidity fortreatment. Other shapes are also possible. For example, the treatmentelement may comprise a generally spherical or cylindrical shape. In someembodiments, the treatment element comprises an angular shape (e.g.,triangular, conical) which may allow for close conformation to thetissue structures. The treatment element 552 comprises a monopolar orbipolar needle array comprising multiple needles 554. In someembodiments, the needles 554 are energized in between select needles todeliver bipolar energy. In other embodiments, the energy is deliveredbetween the needles 554 and a remote grounding pad (not shown). In someembodiments, the electrode needle pairs are arranged horizontally acrossthe treatment element 552. In some embodiments, the electrode needlepairs are arranged vertically across the treatment element 552, or alongthe direction of the shaft 558 and handle 560. Other configurations arealso possible. For example, the needle pairs may be arranged diagonallyacross the treatment element 552. The treatment element 552 may beplaced either internally, with the needle pairs 554 positionedtransmucosally or the treatment element 552 may be placed externallywith the needle pairs 554 positioned transdermally. The distal tip 556of the device 550 may also function as a mold or molding element. In amonopolar embodiment, the energy may be selectively delivered betweencertain sets of needles, all needles, or even individual needles tooptimize the treatment effect.

The treatment element 552 of the device 550 further comprises apin-shaped structure comprising a thermocouple 555 within an insulatingbushing extending through a middle portion of the front surface of thetreatment element 552. In some embodiments, different heat sensors(e.g., thermistors) may be used. As described above, in someembodiments, the thermocouple 555 is configured to measure a temperatureof the surface or subsurface of tissue to be treated or tissue near thetissue to be treated. A pin-shape having a sharp point may allow thestructure to penetrate the tissue to obtain temperature readings frombelow the surface. The thermocouple can also be configured to measure atemperature of the treatment element 552 itself. The temperaturemeasurements taken by the thermocouple can be routed as feedback signalsto a control unit (e.g., the control system 42 described with respect toFIG. 3) and the control unit can use the temperature measurements toadjust the intensity of energy being delivered through the electrode. Insome embodiments, thermocouples or other sensing devices may be used tomeasure multiple tissue and device parameters. For example, multiplethermocouples or thermistors may be used to measure a temperature atdifferent locations along the treatment element. In some embodiments,one of the sensors may be configured to penetrate deeper into the tissueto take a measurement of a more interior section of tissue. For example,a device may have multiple sensors configured to measure a temperatureat the mucosa, the cartilage, and/or the treatment element itself. Asdescribed above, in some embodiments, the sensors described herein areconfigured to take a measurement of a different parameter. For example,tissue impedance can be measured. These measurements can be used toadjust the intensity and/or duration of energy being delivered throughthe treatment element. This type of feedback may be useful from both anefficacy and a safety perspective.

In some embodiments, the treatment element has a width or diameter ofabout 0.25 inches to about 0.45 inches. In some embodiments, thetreatment element is about 0.4 inches to about 0.5 inches long. Thetreatment element can, in some embodiments, comprise a ceramic material(e.g., zirconium, alumina, silicon glass). Such ceramics mayadvantageously possess high dielectric strength and high temperatureresistance. In some embodiments, the treatment element comprisespolyimides or polyamides which may advantageously possess gooddielectric strength and elasticity and be easy to manufacture. In someembodiments, the treatment element comprises thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the treatment elementcomprises thermoset polymers, which may advantageously provide gooddielectric strength and good elasticity. In some embodiments, thetreatment element comprises glass or ceramic infused polymers. Suchpolymers may advantageously provide good strength, good elasticity, andgood dielectric strength.

In some embodiments, the electrodes have a width or diameter of about0.15 inches to about 0.25 inches. In some embodiments, the electrode isabout 0.2 inches to about 0.5 inches long. In some embodiments, thetreatment element comprises steel (e.g., stainless, carbon, alloy).Steel may advantageously provide high strength while being low in costand minimally reactive. In some embodiments, the electrodes or energydelivery elements described herein comprise materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein compriseanodized aluminum. Anodized aluminum may advantageously be highly stiffand low in cost. In some embodiments, the electrodes or energy deliveryelements described herein comprise titanium which may advantageouslypossess a high strength to weight ratio and be highly biocompatible. Insome embodiments, the electrodes or energy delivery elements describedherein comprise nickel titanium alloys. These alloys may advantageouslyprovide high elasticity and be biocompatible. Other similar materialsare also possible.

Energy applied to the tissue to be treated using any combination of theembodiments described in this application may be controlled by a varietyof methods. In some embodiments, temperature or a combination oftemperature and time may be used to control the amount of energy appliedto the tissue. Tissue is particularly sensitive to temperature; soproviding just enough energy to reach the target tissue may provide aspecific tissue effect while minimizing damage resulting from energycausing excessive temperature readings. For example, a maximumtemperature may be used to control the energy. In some embodiments, timeat a specified maximum temperature may be used to control the energy. Insome embodiments, thermocouples, such as those described above, areprovided to monitor the temperature at the electrode and providefeedback to a control unit (e.g., control system 42 described withrespect to FIG. 3). In some embodiments, tissue impedance may be used tocontrol the energy. Impedance of tissue changes as it is affected byenergy delivery. By determining the impedance reached when a tissueeffect has been achieved, a maximum tissue impedance can be used tocontrol energy applied.

In the embodiments described herein, energy may be produced andcontrolled via a generator that is either integrated into the electrodehandpiece or as part of a separate assembly that delivers energy orcontrol signals to the handpiece via a cable or other connection. Insome embodiments, the generator is an RF energy source configured tocommunicate RF energy to the treatment element. For example, thegenerator may comprise a 460 KHz sinusoid wave generator. In someembodiments, the generator is configured to run between about 1 and 100watts. In some embodiments, the generator is configured to run betweenabout 5 and about 75 watts. In some embodiments, the generator isconfigured to run between about 10 and 50 watts.

In some embodiments, the energy delivery element comprises a monopolarelectrode (e.g., electrode 535 of FIG. 22G). Monopolar electrodes areused in conjunction with a grounding pad. The grounding pad may be arectangular, flat, metal pad. Other shapes are also possible. Thegrounding pad may comprise wires configured to electrically connect thegrounding pad to an energy source (e.g., an RF energy source).

In some embodiments, the energy delivery element such as the electrodesdescribed above can be flat. Other shapes are also possible. Forexample, the energy delivery element can be curved or comprise a complexshape. For example, a curved shape may be used to place pressure ordeform the tissue to be treated. The energy delivery element maycomprise needles or microneedles. The needles or microneedles may bepartially or fully insulated. Such needles or microneedles may beconfigured to deliver energy or heat to specific tissues while avoidingtissues that should not receive energy delivery.

In some embodiments, the electrodes or energy delivery elementsdescribed herein comprise steel (e.g., stainless, carbon, alloy). Steelmay advantageously provide high strength while being low in cost andminimally reactive. In some embodiments, the electrodes or energydelivery elements described herein comprise materials such as platinum,gold, or silver. Such materials may advantageously provide highconductivity while being minimally reactive. In some embodiments, theelectrodes or energy delivery elements described herein compriseanodized aluminum. Anodized aluminum may advantageously be highly stiffand low in cost. In some embodiments, the electrodes or energy deliveryelements described herein comprise titanium which may advantageouslypossess a high strength to weight ratio and be highly biocompatible. Insome embodiments, the electrodes or energy delivery elements describedherein comprise nickel titanium alloys. These alloys may advantageouslyprovide high elasticity and be biocompatible. Other similar materialsare also possible.

In some embodiments, the treatment elements (e.g., non-electrode portionof treatment element) of the devices described herein, including but notlimited to FIGS. 8A-J, 9A-B, 10A-B, 11A-B, 12A-B, 13A-E, 14A-B, 15A-C,16, 17A-B, 18, 19A-B, 20A-B, 21A-B, 22A-G, 23A-G, 25A-B, 26, 27, 28A-E,and 29, comprise an insulating material such as a ceramic material(e.g., zirconium, alumina, silicon glass). In some embodiments, thetreatment elements comprise an insulating material interposed betweenmultiple electrodes or electrode section. These insulating sections mayprovide an inert portion of the treatment element that does not deliveryenergy to the tissue. Such ceramics may advantageously possess highdielectric strength and high temperature resistance. In someembodiments, the insulators described herein comprise polyimides orpolyamides which may advantageously possess good dielectric strength andelasticity and be easy to manufacture. In some embodiments, theinsulators described herein comprise thermoplastic polymers.Thermoplastic polymers may advantageously provide good dielectricstrength and high elasticity. In some embodiments, the insulatorsdescribed herein comprise thermoset polymers, which may advantageouslyprovide good dielectric strength and good elasticity. In someembodiments, the insulators described herein comprise glass or ceramicinfused polymers. Such polymers may advantageously provide goodstrength, good elasticity, and good dielectric strength.

In some embodiments, the handle and/or shaft of the devices comprise thesame materials as those described with respect to the insulators. Insome embodiments, the handle and/or shaft of the device comprises ametal, such as stainless steel. In other embodiments, the handle and/orshaft of the device comprises a polymer, such as polycarbonate. Othermetals and polymers are also contemplated.

In some embodiments, the device may be used in conjunction with apositioning element that can be used to aid in positioning of thedevice. The positioning element may be integrated into the device itselfor can be separate. The positioning element may be used to determine theoptimal placement of the device to achieve maximal increase in efficacy.In some embodiments, a positioning element is configured to be insertedand manipulated within the nose until the patient reports a desiredimprovement in breathing. The treatment device may then be used to treatwhile the positioning element is holding the nose in the desiredconfiguration. In some embodiments, molds described herein may be usedfor the same purpose.

In some embodiments, a positioning element comprises a shaft comprisingmeasurement marks indicating depth. For example, a physician may insertthis element into the nose to manipulate the tissue to find the depth oftreatment at which the patient reports the best breathing experience.The positioning element may comprise marks around the base of the shaftindicating which point of rotation of the device within the nostrilprovides the best breathing experience. The positioning element may alsocomprise marks indicating angle of insertion. The physician may then usethe measurement marks to guide insertion of the treatment element to thesame spot.

It will be appreciated that any combination of electrode configurations,molds, handles, connection between handles, and the like may be used totreat the nasal septum.

Examples of Treatment Devices Including Cooling Systems

Embodiments of devices configured to heat specific tissue whilemaintaining lower temperatures in other adjacent tissue are provided.These devices may be incorporated into any of the treatment apparatusesand methods described herein. The nasal septum is an example of a tissuecomplex that includes adjacent tissues that may benefit from beingmaintained at different temperatures. Other examples include the skin,which comprises the epidermis, dermis, and subcutaneous fat, thetonsils, which comprise mucosa, glandular tissue, and vessels. Treatmentof other tissue complexes is also possible. For example, in someembodiments, the nasal septum may be heated while maintaining a lowertemperature in the mucosal lining of the nose and/or skin. In otherembodiments, the cartilage may be heated, while maintaining lowertemperatures in the mucosa. Limiting unwanted heating of non-targettissues may allow trauma and pain to be reduced, may reduce scarring,may preserve tissue function, and may also decrease healing time.Combinations of heat transfer and/or heat isolation may allow directedtreatment of specific tissue such as cartilage, while excluding anothertissue, such as mucosa, without surgical dissection.

Generally, when using a device 570 with an electrode 572 (e.g.,monopolar RF electrode) to heat nasal cartilage, the electrode 572 mustbe in contact with the mucosa. FIG. 24A shows a cross-section of tissueat the nasal septum. The cross-section shows that the nasal cartilage704 sits in between layers of mucosa 702. When the electrode 572 isactivated, both the mucosa and the cartilage are heated by the currentflowing from the electrode to the return (e.g., ground pad), as shown inFIG. 24B. The tissue closest to the electrode 572 receives the highestcurrent density, and thus, the highest heat. A surface cooling mechanismmay allow the temperature of the electrode surface to be reduced. Such acooling mechanism may maintain a lower temperature at the mucosa eventhough current flow will continue to heat the cartilage.

FIG. 25A depicts a device 580 configured to treat the nasal septumcartilage using an electrode while maintaining a reduced temperature atthe mucosa. The device comprises a treatment element 582 comprising anelectrode 584 at the distal tip of the device 580. The treatment element582 is attached to a distal end of a shaft 586, which is attached to thedistal end of a handle 588. Input and output coolant lines 590, 592 areattached to a pump and reservoir 594 and extend into the handle 588,through the distal end of the treatment element 582 to the electrode 582and return back through the shaft 586 and handle 588 to the pump andreservoir 594. The coolant may be remotely cooled in the reservoir andmay comprise a fluid or gas. The coolant flowing through the electrode582 may allow the treatment element 582 to be maintained at a reducedtemperature while still allowing current flow to heat the cartilage.Examples of coolant include air, saline, water, refrigerants, and thelike. Water may advantageously provide moderate heat capacity and benon-reactive. Refrigerants may advantageously be able to transfersignificant amounts of heat through phase change. The coolant may flowthrough internal or external cavities of the electrode or wand tip. Forexample, FIG. 25B depicts an embodiment of a device 600 comprising atreatment element 602 with an electrode 604 at the distal tip of thedevice 600. The treatment element 602 is attached to the distal end of ashaft 606 which is attached to the distal end of a handle 608. Thehandle may be attached to a cable comprises a lumen or channel 611through which gas or fluid may flow. The lumen 611 may diverge, near thetreatment element 602, into separate external channels flowing over theelectrode 604. The lumen 611 and channels 610 or cavities may beattached to a fan or fluid pump 612. In some embodiments, the fan orfluid pump may remotely cool the gas or fluid.

FIG. 26 depicts another embodiment of a device 620 configured to treatthe nasal septum using an electrode 624 while maintaining a reducedtemperature at the mucosa and/or skin. The device comprises a treatmentelement 622 comprising an electrode 624 at its distal end. The treatmentelement 622 is connected to the distal end of a shaft 626 which isconnected to the distal end of a handle 628. The device 620 comprises aheat pipe 630 attached to the electrode 624 or treatment element 622.The heat pipe 630 is configured to transfer heat to a remote heat sink632. As shown in FIG. 26, the heat sink 632 may be placed in the handleof the device. In some embodiments, the heat sink may be placedremotely. The heat pipe 630 may comprise a sealed tube (e.g., a coppertube) filled with a material that evaporates at a given temperature.When one end of the heat pipe 630 is heated, the fluid may evaporate andflow to the opposite end where it may condense and subsequently transferheat to the heat sink 632. Using a material such as copper for the heatpipe 630 and/or heat sink 632 may advantageously provide high heat andelectrical conductivity.

FIG. 27 depicts another embodiment of a device 640 configured to treatthe nasal septum using a bipolar electrode pair while maintaining areduced temperature at the mucosa or the skin. The device 640 comprisesa first treatment element 642 comprising a first electrode 644 of abipolar electrode pair at the distal end of a shaft 646. The treatmentelement 642 comprises a thermocouple pin 650 like that described withrespect to FIG. 22G. The shaft 646 is connected to the distal end of ahandle 648. The handle 648 is connected to another handle 652 comprisinga shaft 654 with a treatment element 656 at its distal tip. Thetreatment element 656 comprises a second electrode 657 of the bipolarelectrode pair. The first and second treatment elements 642, 656 can beplaced on either side of nasal tissue. For example, the first treatmentelement 642 may be in contact with the mucosa and the second treatmentelement 656 may be in contact with the skin. Similar to the devicedepicted in FIG. 26, the device of FIG. 27 comprises a heat pipe withinboth shafts 654, 646. Thus heat from the tissue is transferred from thetreatment elements 642, 656 and is transported down the shafts 654, 646into an integrated or a remote heat sink (not shown). This heat transfermay keep the skin and/or the mucosa relatively cool while stilldelivering sufficient treatment energy to the cartilage. The connection658 and spring 647 between the two handles 648, 652 is configured tobias the two shafts 646, 654 and treatment elements 642, 656 towards acollapsed state. Squeezing the handles 648, 652 may separate the twoshafts 646, 654 and treatment elements 642, 656. Thus, the handles 648,652 can be squeezed to properly position the device 640 at the nasaltissue to be treated. Releasing the handles 648, 652 can cause thetreatment element 642 and the cooling element 656 to contact the tissue.In some embodiments, the device 640 may only comprise one heat pipe. Insome embodiments, the device 640 may comprise a treatment element with amonopolar electrode on one shaft and a molding element on the othershaft. Multiple configurations are contemplated. For example, the devicemay comprise one heat pipe and a bipolar electrode pair. For anotherexample, the device may comprise one heat pipe and a monopolarelectrode. For another example, the device may comprise two heat pipesand a monopolar electrode. Other device configurations are alsopossible.

The embodiments described with respect to FIGS. 25A-27 employ specificdifferential cooling mechanisms to maintain different and particulartemperatures in adjacent tissues. FIGS. 28A-28E depicts various examplesof more general mechanisms configured to maintain different temperaturesin adjacent tissues. FIGS. 28A-28E depict examples of differentialcooling mechanisms as applied to a cross-section of tissue at the nasalseptum, like that shown in FIG. 24A. The nasal septum may include amiddle cartilage layer 704 with mucosal tissue 702 on either side.

As shown in FIG. 28A, in some embodiments, the differential coolingmechanism comprises two elements: a first element 708 and a secondelement 710. The two elements are on either side of the thickness of thenasal tissue. In one embodiment, the mechanism is configured to maintainnormal temperatures in the cartilage 704 while cooling mucosal tissue702 on a first side and mucosal tissue 702 on a second side. In such anembodiment, the first and second elements 708, 710 comprise a coolingapparatus such as those described above (e.g., heatsink, coolant lines,etc.). In some embodiments, the mucosal tissue 702 on the first andsecond sides is heated while normal temperatures are maintained in thecartilaginous middle layer 704. The cartilage 704 may be somewhatwarmed, in such embodiments, but may be cooler than mucosal tissue 702on the first and second sides. In such embodiments, the first and secondelements 708, 710 comprise a heating apparatus, such as radio frequencyelectrodes or resistive heating elements. In some embodiments, mucosaltissue 702 on the first side is heated, the mucosal tissue 702 on secondside is cooled, and normal temperatures are maintained in the cartilage704. In such embodiments, the first element 708 comprises a heatingapparatus and the second element 710 comprises a cooling apparatus. Forexample, the device 580, described with respect to FIG. 27, may use sucha mechanism. In some embodiments, the second side is heated, the firstside is cooled, and normal temperatures are maintained in the cartilage704. In such embodiments, the first element 708 comprises a coolingapparatus and the second element 710 comprises a heating apparatus.Again, the device 580, described with respect to FIG. 27, is an exampleof a device that may use such a mechanism.

FIG. 28B shows an example of one of the embodiments described withrespect to FIG. 28A. The first element 730 is on mucosal tissue 702 on afirst side of the nasal septum. The second element 732 is an energydelivery element and is positioned on mucosal tissue 702 on a secondside of the nasal septum. The first element 730 comprises a coolingapparatus and the second element 732 comprises an energy deliveryelement (e.g., an RF electrode). The a first side is cooled while asecond side and cartilaginous areas 704 are heated. In otherembodiments, the first element 730 can be positioned on mucosal tissue702 on the second side and the second element 732 can be positioned onmucosal tissue 702 on the first side. In such embodiments, the mucosaltissue 702 on the second side is cooled while mucosal tissue 702 on thefirst side and the cartilage 704 are heated.

As shown in FIG. 28C, in some embodiments, the differential coolingmechanism comprises a first element 720 and a second element 722. Bothelements 720, 722 are on mucosal tissue 702 on the first side of thenasal septum. In some embodiments, the mucosal tissue 702 on the firstside is cooled while higher temperatures are maintained in the middlecartilaginous layer 704. In such embodiments, the first element 720comprises a cooling apparatus, and the second element 722 comprises anenergy delivery apparatus (e.g., a monopolar radiofrequency electrode).In some embodiments, the first element 720 is sufficiently efficient tomaintain cool temperatures at mucosal tissue 702 on the first sidedespite the energy provided by the second element 722. In otherembodiments, the first and second elements 720, 722 are both positionedon mucosal tissue 702 on the second side of the nasal septum. In suchembodiments, mucosal tissue 702 on the second side is cooled whilehigher temperatures are maintained in the middle cartilaginous layer.

As shown in FIG. 28D, in some embodiments, the differential coolingmechanism comprises a first surface element 740 and a second surfaceelement 742 on either side of the nasal septum. A third subsurfaceelement 744 is engaged through the mucosal tissue 702 on the first sideand into the cartilage area 704. In some embodiments, the mucosal tissue702 on the first side and the second side are cooled while the middlecartilaginous layer 704 is heated. In such embodiments, the first andsecond elements 740, 742 comprise cooling apparatus while the thirdelement 744 comprises a heating element (e.g., RF monopolar electrode,RF bipolar needles, etc.). In other embodiments, the third subsurfaceelement 744 may be engaged through the mucosal tissue 702 on the secondside and into the cartilage area 704.

As shown in FIG. 28E, in some embodiments, the differential coolingmechanism comprises a first surface element 750 and a second surfaceelement 752 on either side of the nasal septum. The differential coolingmechanism further comprises a third surface element 754 and a fourthsurface element 756 on either side of the nasal septum. In someembodiments, the cartilage layer 704 is heated while the mucosal tissue702 on the first and second sides are cooled. In such embodiments, thefirst and second elements 750, 752 comprise cooling apparatus and thethird and fourth elements 754, 756 comprise energy delivery apparatuses(e.g., bipolar plate electrodes). In some embodiments, the cartilage 704and mucosal tissue 702 on the first side are heated while the mucosaltissue on the second side is cooled. In such embodiments, the firstelement 750 comprises a heating apparatus; the second element 752comprises a cooling apparatus; and the third and fourth elements 754,756 comprise energy delivery apparatuses. It will be appreciated thatdifferent differential temperature effects can be achieved byreconfiguring and adding or subtracting to the described configurationof elements.

Cooling occurring before, during, or after treatment may effect reducedtemperature of the skin and/or mucosa. In some embodiments, attachingpassive fins or other structures to the electrode or wand tip may allowfor heat dissipation to the surrounding air. In some embodiments, thedevice may be configured to spray a cool material such as liquidnitrogen before, during, or after treatment. Using a material such ascopper for the passive fins or other structure may advantageouslyprovide high heat and electrical conductivity. In some embodiments,using metals with a high heat capacity in the device (e.g., in theenergy delivery element, the reshaping element, or both) mayadvantageously provide the ability to resist temperature change duringenergy delivery. In some embodiments, pre-cooling the electrode (e.g.,by refrigeration, submersion, spraying with a cool substance like liquidnitrogen, etc.) may maintain a reduced temperature at the mucosa. Anycombination of the cooling methods described herein may be used inconjunction with any of the energy delivery methods described herein(e.g., bipolar RF electrodes, arrays needles, plates, etc.). Forexample, FIG. 29 depicts an embodiment of a device 800 comprising atreatment element 802 comprising electrode needles 804 at its distaltip. The device 800 may be used in conjunction with a separate coolingdevice 810 which may comprise channels 811 or cavities to circulate airor fluid. The independent cooling device 810 may, in other embodiments,employ a different cooling mechanism.

In embodiments using laser energy to heat cartilage, it is possible touse a combination of two or more lasers whose beams converge at alocation within the target tissue. This convergence may cause more heatat that junction as compared to locations where only a single beam isacting. The junction may be controlled manually or via computer control.Specific treatment may be provided.

In some embodiments, insulating material may be used to protectnon-target tissue during energy delivery. For example, an electrodeneedle may be preferentially insulated on a portion of the needle thatis in contact with non-target tissue. For another example, flatelectrode blades may be insulated on a portion of the blade that is incontact with non-target tissue. Other configurations for heat isolationare also possible.

Any of the cooling mechanisms or combinations of the cooling mechanismsdescribed herein may be used in conjunction with any of the devices orcombinations of devices described herein, or the like.

Examples of Methods of Treatment

Embodiments of methods for treating nasal airways are now described.Such methods may treat nasal airways by decreasing the airflowresistance or the perceived airflow resistance at the site of a nasalseptum. Such treatments may also address related conditions, such assnoring. The methods may include using a device similar to those devicesdescribed above—including but not limited to FIGS. 8A, 9B, 18, 22A-G,and 23A-G—to provide tissue reshaping/molding and to impart energy totissue near the nasal septum.

In one embodiment, a method of decreasing airflow resistance in a nosecomprises the steps of inserting an energy-delivery or cryo-therapydevice into a nasal passageway, and applying energy or cryo-therapy to atargeted region or tissue of the nasal passageway. For example, in someembodiments, the method may include delivering energy or cryo-therapy toa section of nasal septum cartilage. Energy and cryo-therapy can beapplied to cartilage in the area of the upper lateral cartilage, or inthe area of intersection of the upper and lower lateral cartilage. Inalternative embodiments, the method may deliver energy to theepithelium, or underlying soft tissue adjacent to the nasal septum, theupper lateral cartilage and/or the intersection of the ULC and the LLC.

In another embodiment, a method comprises heating a section of nasalseptum cartilage to be reshaped, applying a mechanical reshaping force,and then removing the heat. In some embodiments, the step of applying amechanical reshaping force may occur before, during or after the step ofapplying heat.

In some embodiments, the method may further include the step ofinserting a reshaping device into the nasal passageway after applying anenergy or cryo-therapy treatment. In such embodiments, a reshapingdevice such as an external adhesive nasal strip (such as those describedfor example in U.S. Pat. No. 5,533,499 to Johnson or U.S. Pat. No.7,114,495 to Lockwood, the entirety of each of which is herebyincorporated by reference) may be applied to the exterior of the noseafter the treatment in order to allow for long-term reshaping of nasalseptum structures as the treated tissues heal over time. In alternativeembodiments, a temporary internal reshaping device (such as those taughtin U.S. Pat. No. 7,055,523 to Brown or U.S. Pat. No. 6,978,781 toJordan, the entirety of each of which is hereby incorporated byreference) may be placed in the nasal passageway after treatment inorder to allow for long-term reshaping of nasal septum structures as thetreated tissues heal over time. In some embodiments, the dilating nasalstrips can be worn externally until healing occurs.

In alternative embodiments, internal and/or external reshaping devicesmay be used to reshape a nasal septum section prior to the step ofapplying energy or cryo-therapy treatments to targeted sections of theepithelial, soft tissue, mucosa, submucosa and/or cartilage of the nose.In some embodiments, the energy or cryo-therapy treatment may beconfigured to change the properties of treated tissues such that thetissues will retain the modified shape within a very short time of thetreatment. In alternative embodiments, the treatment may be configuredto reshape nasal septum structures over time as the tissue heals.

In some embodiments, a portion of the nose, the nasal septum and/or thesoft tissue and cartilage of the nasal valve may be reshaped using areshaping device and then fixed into place. In some embodiments, suchfixation may be achieved by injecting a substance such as a glue,adhesive, bulking agent or a curable polymer into a region of the nasaltissue adjacent the target area. Alternatively, such a fixationsubstance may be applied to an external or internal surface of the nose.

In some embodiments, an injectable polymer may be injected into a regionof the nose, either below the skin on the exterior of the nose, or underthe epithelium of the interior of the nose. In some embodiments, aninjectable polymer may include a two-part mixture configured topolymerize and solidify through a purely chemical process. One exampleof a suitable injectable two-part polymer material is described in U.S.Patent Application Publication 2010/0144996, the entirety of which ishereby incorporated by reference. In other embodiments, an injectablepolymer may require application of energy in order to cure, polymerizeor solidify. A reshaping device may be used to modify the shape of thenasal septum before or after or during injection of a polymer. Inembodiments employing an energy-curable polymer, a reshaping device mayinclude energy-delivery elements configured to deliver energy suitablefor curing the polymer to a desired degree of rigidity.

In another embodiment, the soft tissue of the upper lip under the naresmay be debulked or reshaped to reduce airflow resistance. In someembodiments, such reshaping of the upper lip soft tissue may be achievedby applying energy and/or cryotherapy from an external and/or internaltreatment element. In some embodiments, the tissue of the upper lipunder the nares may be compressed by an internal or external deviceprior to or during application of the energy or cryo-therapy. Forexample, devices such as those shown in FIGS. 5A and 5B may be adaptedfor this purpose by providing tissue-engaging clamp tips shaped for thepurpose.

In another embodiment, the muscles of the nose and/or face arestimulated to affect (e.g., dilate) the nasal septum area prior to orduring application of other treatments such as energy/cryo applicationor fixation treatments. In such embodiments, the muscles to be treatedmay include the nasal dilator muscles (nasalis) the levator labii, orother facial muscles affecting the internal and/or external nasalvalves. In some embodiments, the targeted muscles may be stimulated byapplying an electric current to contract the muscles, mentally by thepatient, or manually by the clinician.

In some embodiments, the muscles of the nose and/or face may also beselectively deactivated through chemical, ablative, stimulatory, ormechanical means. For example, muscles may be deactivated by temporarilyor permanently paralyzing or otherwise preventing the normal contractionof the muscle tissue. Chemical compounds for deactivating muscle tissuesmay include botulinum toxin (aka “Botox”), or others. Ablativemechanisms for deactivating muscle tissue may include RF ablation, laserablation or others. Mechanical means of deactivating muscle tissues mayinclude one or more surgical incisions to sever targeted muscle tissue.

In another embodiment, the tissue of the nasal septum may be reshaped byapplying energy to the internal and external walls of the nose using aclamp like device as illustrated for example in FIGS. 5A and 5B. One armof the clamp may provide inward pressure to the external, skin sidetissue covering nasal tissue and the other side of the clamp may provideoutward pressure to the mucosal tissue on nasal tissue (e.g., thelateral wall of the nasal airway above the ULC and LLC or both).

In some embodiments, energy may be applied to the skin of the nose toeffect a shrinkage of the skin, epidermis, dermis, subdermal,subcutaneous, tendon, ligament, muscle, cartilage and/or cartilagetissue. The tissue shrinkage is intended to result in a change of forcesacting on the tissues of the nasal septum.

In another embodiment, the nasal septum tissue may be damaged orstimulated by energy application, incisions, injections, compression, orother mechanical or chemical actions. Following such damage, a devicemay be used on the tissue to mold or shape the tissue of the septumduring healing. In some embodiments, such a reshaping device may betemporarily placed or implanted inside or outside the patient's nose tohold a desired shape while the patient's healing process progresses.

In another embodiment, the aesthetic appearance of the nose may beadjusted by varying the device design and/or treatment procedure. Thepredicted post-procedure appearance of the nose may be shown to thepatient through manipulating the nasal tissue to give a post procedureappearance approximation. The patient may then decide if the predictedpost procedure appearance of the face and nose is acceptable or if thephysician needs to change parameters of the device or procedure toproduce an appearance more acceptable to the patient.

In another embodiment, reduction of the negative pressure in the nasalairway can be effected to reduce collapse of the structures of the nasalairway on inspiration without changing a shape of the nasal septum. Forexample, this may be accomplished by creating an air passage that allowsflow of air directly into the site of negative pressure. One example ofthis is creating a hole through the lateral wall of the nose allowingairflow from the exterior of the nose through the nasal wall and intothe nasal airway.

In another embodiment, energy, mechanical or chemical therapy may beapplied to the tissue of the nasal airway with the express purpose ofchanging the properties of the extracellular matrix components toachieve a desired effect without damaging the chondrocytes or othercells of the nasal airway tissue.

In some embodiments, devices (e.g., devices like those described withrespect to FIGS. 9A-21B) may be used to provide tissue reshaping/moldingand to impart energy to the nasal septum. The electrode may be placed incontact with the target nasal septum tissue. The electrodes and moldsmay be moved to shape the tissue as necessary to achieve improvement innasal airway. The electrodes may be activated while the tissue isdeformed in the new shape to treat the tissue. The electrode may then bedeactivated and the device may be removed from the nasal septum area.

FIGS. 30A-D show an embodiment of a method for modifying a nasal septum,viewed from the nares. FIG. 30A illustrates a view of a nose having adeviated nasal septum 2. FIG. 30B illustrates a substance deliverydevice 806 (shown as a syringe with needle, but alternatively a swab orany other device for applying a substance to the tissue) applying asolution 808 to tissue near the cartilage of the nasal septum 2. FIG.30C illustrates an energy delivery device 800 with a treatment elementapplying energy to the nasal septum. FIG. 30D illustrates a view of thenose after treatment, having a corrected nasal septum 2.

The method may include identifying a patient who desires to improve theairflow through their nasal passageways and/or who may benefit from amodification to the nasal septum (e.g., the patient has a deviatedseptum as shown in FIG. 30A). The patient may be positioned either in anupright position (e.g., seated or standing) or lying down. Localanesthesia may be applied to an area near or surrounding the tissue tobe treated. General anesthesia may also be used.

The physician (or other medical professional administering thetreatment) may apply a chemical enzyme or other solution at the site ofthe deviation to be corrected (see, e.g., FIG. 30B). In one embodiment,for example, the physician injects the solution through mucosal tissueto the space between the nasal mucosa and the nasal septal cartilage.The solution may be contained in the general area of the septaldeviation, using a shield, and may be left in the patient's septum for adesignated amount of time, to allow the solution to effectivelycondition the septal cartilage.

In some embodiments, the solution is between about 0.5 ml to about 2.5ml of collagenase at a concentration ranging from about 1 mg/ml to about10 mg/ml. In an example, a solution can include collagenase at aconcentration of approximately 2 mg/ml. In some embodiments, thesolution is between about 0.5 ml to about 2.5 ml of trypsin at aconcentration of about 10 μg/ml to about 100 μg/ml. In an example, asolution can include trypsin at a concentration of approximately 50μg/ml. The designated amount of time may be in the range of about 15minutes to about 90 minutes, in various embodiments. The designatedamount of time can vary based in part on the solution being used. In anexample, the designated amount of time can be approximately 40 minuteswhere the solution includes trypsin at a concentration of approximately50 μg/ml. In an example, a designated amount of time can beapproximately 20 minutes for a solution that includes collagenase at aconcentration of approximately 2 mg/ml. The application of the solutionmay result in a narrow band of degraded cartilage ranging from about 100μm to about 1 mm from the cartilage surface in the area of application.Prior to the application of the solution, the solution may be preparedat a particular temperature (e.g., between about 20° C. and about 80°C., or at about 20° C., 37° C., 60° C., or 80° C.).

At the conclusion of the conditioning period, a device (e.g., amonopolar, bipolar, single electrode, or multi-electrode RF energydevice) may be introduced to the area to be corrected, and energy (e.g.,RF energy) may be applied to the site (see, e.g., FIG. 30C). Thetemperature and duration of the energy application may be selected todenature and/or deactivate the solution and/or reshape the septalcartilage to correct the septal deviation (see, e.g., FIG. 30D). Inaddition to energy, mechanical force can also be applied to aid inreshaping the cartilage. Reshaping the cartilage can include increasinga nasal cross-sectional area with or without changing a nasal valveangle. Reshaping the cartilage can include changing a nasal valve angle.Reshaping the cartilage can include other modifications. The cartilagecan completely, substantially, or partially maintain its shape (e.g., acorrected deviation shape) after the device is removed and the affectedtissue heals.

Optionally, a positioning element, like that described herein, may beused to measure a desired depth or angle of treatment. As describedabove, the positioning element may be be inserted to the desired depthof treatment and rotated to a desired angle of treatment. Marks alongthe positioning element can indicate the desired depth. Marks along thebase of the shaft of the positioning element can indicate the desiredangle. The physician or other medical professional administering thetreatment can then insert the treatment device to the desired location.The physician may also assess any other characteristics relevant to thetreatment of the patient's nose that may influence the manner oftreatment. In some embodiments, a reshaping element may be used tomanipulate the nasal tissue into a configuration allowing improvedairflow; and treatment may be performed while such a reshaping elementis maintaining the desired configuration of the nasal tissue.

If the treatment device includes a monopolar electrode or electrodeneedles, a ground pad may be attached to the patient. The ground pad maybe attached at the patient's torso, for example the shoulder or abdomen.Other locations are also possible, such as the patient's buttocks.Preferably, the point of attachment is a large, fleshy area. After beingattached, the ground pad may be plugged into a power source. If thedevice is powered by a remote generator (e.g., RF generator), the devicemay then be plugged into the generator.

FIGS. 30E-30H depict an embodiment of a method for treating nasalairways. FIG. 30E depicts the nose of a patient after the solution hasbeen applied to tissue to be treated, but prior to insertion of a devicefor heating and reshaping tissue. As shown in FIG. 30F, a device 800 isthen inserted into a nostril of the patient. The treatment element 802of the device 800 may be positioned within the nasal airway, adjacent tothe nasal tissue (e.g., nasal septum) to be treated. The treatmentelement 802 may be positioned so that the electrode is in contact withthe tissue to be treated. The device 800 (as shown in FIG. 30G) includesmultiple needle electrodes 804, although in alternative embodiments theelectrodes 804 might not be needles. The needle electrodes 804 may beinserted so that they are penetrating or engaging tissue to be treated.

The treatment element 802 may be used to deform the nasal tissue into adesired shape by pressing a convex surface of the treatment element 802against the nasal tissue to be treated. FIG. 30G shows an internal view,from the nares, of the treatment element 802 pushing against the nasalseptum and deforming the nasal septum. FIG. 30H depicts an external viewof the treatment element 802 deforming the nasal septum. In someembodiments, even from the outside, the nose appears to be bulging nearthe area to be treated. In some embodiments, the deformation required totreat the nose is not visually detectable. A control input, such asbutton 814 may be used to activate the electrode and deliver energy(e.g., RF energy) to the tissue to be treated.

In some embodiments, temperature of the area around the electrode duringtreating is from about 30° C. to about 90° C. In some embodiments,temperature of the area around the electrode during treating is fromabout 40° C. to about 80° C. In some embodiments, temperature of thearea around the electrode during treating is from about 50° C. to about70° C. In some embodiments, temperature of the area around the electrodeduring treating is about 60° C. In some embodiments, for example duringcryo-therapy, temperature of the area around the electrode may be lower.In some embodiments, the temperature is measured at the target tissuerather than the area around the electrode during treating.

In some embodiments, treating the target tissue includes treatment forabout is to about 3 minutes. In some embodiments, treating the targettissue includes treatment for about 10 seconds to about 2 minutes. Insome embodiments, treating the target tissue includes treatment forabout 15 seconds to about 1 minute. In some embodiments, treating thetarget tissue includes treatment for about 20 seconds to about 45seconds. In some embodiments, treating the target tissue includestreatment for about 30 seconds.

In some embodiments, treating the target tissue includes deliveringbetween about 1 and about 100 watts to the tissue. In some embodiments,treating the target tissue includes delivering between about 5 and about75 watts to the tissue. In some embodiments, treating the target tissueincludes delivering between about 10 and about 50 watts to the tissue.In some embodiments, the wattage is selected based on an amount ofwattage needed to produce a desired temperature at a particularlocation. In some embodiments, wattage is selected based on an amount ofwattage used to produce a temperature of 60° C. in the cartilage.

As shown in FIGS. 30F and 30H, a thermocouple 812 may be provided on theelectrode (e.g., as described with reference to FIGS. 22G and 27). Insome embodiments, more than one thermocouple may be provided. Forexample, in embodiments comprising more than one electrode or electrodepair, each electrode or electrode pair may include a thermocouple. Thethermocouple 812 may monitor temperature of the electrode and providefeedback to a control unit (e.g., control system 42 described withrespect to FIG. 3). The control unit may use the data from thethermocouple 812 to regulate temperature and auto-shutoff once treatmenthas been achieved or in the case of an overly high temperature.

After treating the tissue, the device 800 may be removed from thenostril. If a grounding pad is used, the grounding pad may be detachedfrom the patient.

In some embodiments, differential cooling mechanisms may be used totreat the nasal septum using electrodes or other energy deliveryelements while maintaining a reduced temperature at the skin and/ormucosa. For example, devices like those described with respect to FIGS.25A-27 or devices employing the differential cooling mechanismsdescribed with respect to FIGS. 28A-28E may be used. The cooling systemmay be activated. The device may then be inserted into the nose andplaced in contact with the nasal septum. The device may then beactivated. Activation of the device may cause an increase in thecartilage temperature while minimizing the temperature increase in theskin and/or mucosa. The device may then be deactivated and removed fromthe nose.

In some embodiments, devices may be used in which insulating material isused to protect non-target tissue during energy delivery. In anembodiment, a device includes an electrode needle preferentiallyinsulated on a portion of the needle. The needle may be inserted intothe cartilage so that the insulated portion is in contact with themucosa and/or the skin and the non-insulated portion is in contact withthe cartilage. The device may be activated, causing an increase in thecartilage temperature while minimizing temperature increase in the skinand/or mucosa. The device may be deactivated and removed from the nose.

Additional Embodiments and Optional Features

Referring now to FIGS. 31A and 31B, in one embodiment, a device 900 fortreating a nasal valve may include an internal power source and thus becordless. In the embodiment shown, the device 900 includes a handle 902coupled with a shaft 904, which in turn is coupled with a treatmentelement 908. The handle 902 may include a power button 910 (or “on/offswitch”), a circuit board (912, FIG. 31B) and a space and connectionsfor insertion of batteries 914 as a power source. Treatment element 904may include multiple needle electrodes 906 for applying RF energy totissue.

Any suitable features, elements, materials or the like that have beendescribed above may be applied to the device 900 in a similar way. Invarious alternative embodiments, the device 900 may include any number,size or type of batteries, depending on the size of the handle 902 andpower requirements of the device 900. In some alternative embodiments,the device 900 may include an alternative power source. For example, thebatteries 914 may be rechargeable in some embodiments. In otherembodiments, it may be possible to plug the device 900 into a powergenerator for charging, and then unplug the device 900 for use. In yetother alternative embodiments, the device 900 may include a solar powercollection member. The advantage of including an internal power sourcein the device 900 is that this eliminates the need for the device 900 tobe connected, via power cord, to a large, table-top generator, as mostenergy delivery surgical/medical devices require. This allows aphysician to perform a nasal valve procedure in any location or patientorientation without having to manage power cables and generators.

Referring now to FIGS. 32A and 32B, in some embodiments, a system fortreating a nasal valve or a nasal septum may include one or moresensors. Such sensors may be used to sense any of a number of relevanttissue properties, such as temperature, impedance and the like. Thesensors may be located on a treatment device in some embodiments, oralternatively they may be separate from the treatment device andpositioned at or near the device during treatment. In some embodiments,the sensor(s) may provide feedback directly to the treatment device. Forexample if a particular tissue temperature threshold is reached, asensor (or sensors) may send a signal to a power generator to shut downor decrease power delivered to a treatment device. In alternativeembodiment, the sensor(s) may instead provide feedback to a physician orother user, so that the physician or other user can make treatmentadjustments. For example, sensors may provide a warning signal when aparticular tissue temperature or impedance is reached, which will help aphysician know when to turn off or decrease power delivery to atreatment device. Additionally, sensor(s) may be used to sense one ormore tissue properties in any suitable tissue or multiple tissues, suchas but not limited to mucosa, cartilage, dermis, epidermis and othertypes of body soft tissue.

FIG. 32A illustrates nasal skin in cross section, including mucosa,cartilage, dermis and epidermis. In one embodiment, a sensor device 920may include an epidermal sensor 922 that is coupled to the epidermis viaan adhesive 924. Any suitable sensor 922 (temperature, impedance, etc.)and any suitable adhesive 924 may be used. This embodiment of the sensordevice 920 is also illustrated on a patient's face in FIG. 32B.

In an alternative embodiment, a sensor device 930 may include atransdermal needle sensor 932. In another alternative embodiment, asensor device 942 may be attached directly to a treatment device 940. Asillustrated by these various embodiments, sensors 922, 932 and 942 maybe positioned either at or near a treatment location during a treatment.In some embodiments, for example, a sensor 922, 932 may be placed on orin epidermis while a treatment is being performed on mucosa and/orcartilage. Alternatively, a sensor 942 may be placed directly on mucosaor cartilage during a treatment of mucosa or cartilage. Additionally, inany given embodiment, multiple sensors may be placed at multipledifferent locations in and/or on tissue. As mentioned above, the sensordevices 920, 930 and 940 may, in various embodiments, provide any of anumber of different types of feedback, such as feedback to a user,feedback to a power generator, or both.

Referring now to FIGS. 33A and 33B, in some embodiments, a treatmentdevice 950 may include a treatment element 952 with wings 954 extendinglaterally from it. The wings 954 are configured to help direct thetreatment element 952 into a particular treatment location/positionand/or to prevent the treatment element 952 from contacting tissue thatthe physician does not want to treat. For example, FIG. 33B illustratesa top, cross-sectional view of a nose N, showing the lateral wall LW,nasal septum S and an intersection I between the lateral wall LW andnasal septum S. The wings 954 help prevent the treatment element 952from being advanced far enough to reach an undesired treatment area.Alternative embodiments may include additional wings or otherprotrusions or shapes to prevent contact with particular structures.Some embodiments may include adjustable wings or wings that expand oncethe electrodes have been placed. Any other size, shape or configurationof one of more wings may be included, according to various embodiments.

Referring to FIGS. 34A-34C, in various alternative embodiments,treatment elements of nasal valve treatment devices may have differentshapes and/or sizes for addressing different types and/or shapes oftissue. For example, as shown in FIG. 34A, in one embodiment, atreatment element 960 of a device may have a square or rectangularprofile with a flat distal end, which may be ideal for addressingrelatively flat tissue configurations. Two electrodes 962 (or two setsof electrodes) may be used to send an arc of current (e.g., RF current)through tissue in the pattern shown by the multi-headed arrow.

In another embodiment, as shown in FIG. 34B, a treatment element 970 mayhave an oval profile with a curved distal end. Two electrodes 972 orsets of electrodes send a current through tissue in an arc. Thisconfiguration may be advantageous for addressing tissue having a curvedprofile. In yet another embodiment, as shown in FIG. 34C, a treatmentelement 980 may have a flatter curved profile, for example foraddressing tissue with a curved shape but not as sharp of an angle asthe tissue shown in FIG. 34B. Again, the electrodes 982 send energythrough the curved tissue in a curved arc.

As is evident from FIGS. 34A-34C, a treatment element of a treatmentdevice may have any suitable configuration for advantageously addressingany tissue type and shape. In some embodiments, multiple differenttreatment devices, each having a differently shaped treatment element,may be provided, and a user may select a treatment device for aparticular tissue type and/or shape, based at least in part on the shapeof the treatment element of the device.

Referring to FIG. 35, in another embodiment, a treatment device 1000 fortreating a nasal septum and/or tissues near the nasal septum may includean expandable member 1002, such as but not limited to an expandablepolymeric balloon. For example, a non-compliant or semi-compliantballoon may be used in some embodiments to expand tissues in and/oraround the nasal valve, to achieve one or more of the effects discussedabove in relation to the various embodiments. Although expandableballoon devices (e.g., balloon catheters) have been described previouslyfor use in expanding ostia (openings) of the sinus cavities, they havenot been described for use in changing the shape and/or physicalcharacteristics of the nasal valve. In various method embodiments, theexpandable member 1002 may be positioned at any of a number of suitablelocations at or near a nasal valve and then expanded to deform tissuesthat make up the nasal septum. In some cases, these tissues may be atleast partially deformed permanently or at least for a period of timeafter the procedure. In other cases, the tissue may only be deformedduring the procedure, but one or more properties of the tissue may beaffected by the balloon expansion.

In various alternative embodiments, a treatment device for nasal septumtissue and/or other nasal tissue may use a treatment modality that doesnot involve delivery of energy to, or removal of energy from, tissue.For example, in some embodiments, the treatment device may create somekind of mechanical injury to one or more tissues to cause a change inshape and/or one or more properties of the tissue. The expandableballoon embodiment described above is one example. Other examples mayinclude, but are not limited to, needles, micro-needles, blades or thelike, any of which may be used to cause scar tissue formation and/ortissue contraction. Other embodiments may use sclerotherapy, involvinginjecting one or more substances (acid, coagulants, etc.) into thetarget tissue to induce scar tissue formation and/or other changes inthe tissue properties. In some cases, one type of tissue (for example,mucosa or cartilage) may be transformed into a different type of tissuealtogether (for example, scar tissue). In other examples, one or moreproperties of the tissue may be changed without changing the overalltype of tissue. For example, the tissue may be caused to shrink,contract, stiffen and/or the like. One advantage of thesenon-energy-based embodiments is that they do not require a source ofenergy. This may make them easier to use and possibly to manufacture andsupply.

In other embodiments, thermal energy may be applied to the nasal tissueby applying the energy from an external location on the nose, ratherthan an internal location within the nasal cavity. For example, in someembodiments, a treatment device may be positioned on the nose and usedto deliver thermal energy through the epidermis to the nasal septum. Insome embodiments, the treatment device may also be used to cool thesuperficial dermis and epidermis, for example. This delivery of energymay, in some embodiments, act to tighten tissues of the nasal valve,thus preventing collapse during breathing. In an alternative embodiment,instead of using thermal energy to change the tissues, a treatmentdevice may use mechanical means, such as micro-needles, to create asubdermal tissue response, such as scarring, for a similar type oftissue tightening effect.

In yet other embodiments, some methods for treating a nasal valve mayinclude applying a gel, paste, liquid or similar substance to a surfaceof the nose during an energy delivery treatment of the nasal valve. Suchsubstances may be applied to target tissue, such as mucosa, non-targettissue, such as epidermis, or a combination of both. The substance (orsubstances) applied may serve any of a number of different purposes,such as but not limited to modifying conductivity of tissue andproviding anesthetic effect. Conductivity enhancing substances mayimprove the efficiency and/or consistency of energy delivery (such asbut not limited to RF energy). Alternatively or additionally, one ormore substances may be injected into tissue. For example, saline,Lidocaine, other anesthetic agents, or any other suitable agents, may beinjected. Some embodiments may involve applying one substance andinjecting another substance.

In other alternative embodiments, it may be possible to achieve desiredchanges in tissue properties and/or shapes by injecting substance orapplying substance only—in other words, without also applying energy.For example, injecting a sclerotherapy substance into tissue may, insome embodiments, achieve a desired tissue result. In additionalalternative embodiments, a method of treating a nasal septum may includeinjecting a substance into nasal tissue and then curing the substance inorder to change the substance's properties and, in turn, at least one ofthe nasal tissue's properties. A treatment device may be used to curethe substance. In some embodiments, the treatment device may be used todeform the target tissue and cure the substance, while the tissue isdeformed, so that the tissue retains approximately the same, deformedshape after the substance is cured and the treatment device is removed.In another alternative embodiment, a surface-based biodegradable agentmay be applied and cured to change the shape of the target nasal tissue.

FIGS. 36A-36E illustrate a method and device for treating a septum 1102having a deviation 1104, according to some embodiments. The method anddevice of FIGS. 36A-36E may include one or more features of previouslydescribed treatment methods and devices, including but not limited tothose described in relation to FIGS. 30A-30H.

FIG. 36A illustrates septum 1102 and deviation 1104 as though lookinginto a patient's left nostril. FIG. 36B illustrates an enlarged detailview of septum 1102 and deviation 1104.

FIG. 36C illustrates an applicator 1106 applying a treatment solution todeviation 1104. As illustrated, applicator 1106 is an injection deviceused to inject the treatment solution in an area of deviation 1104, butother application methods and applicators may be used. Other applicationmethods include, but are not limited to, topical application, diffusion,current-driven application, electrophoresis, and any other method ofapplying a solution and/or enzymes to target tissue. The solution may beleft to act for a designated dwell time to allow the solution toeffectively condition the septal cartilage. The dwell time may be in therange of about 1 minute to about 60 minutes, about 1 minute to about 40minutes, about 1 minute to about 20 minutes, about 1 minute to about 10minutes, about 1 minute to about 5 minutes, or other ranges. In someembodiments, the dwell time is less than one minute. In someembodiments, there is approximately no dwell time at all.

FIG. 36D illustrates a treatment device 1110 being used to correctdeviation 1104. As illustrated, treatment device 1110 includes a handle1112, a first elongate shaft 1114 extending from handle 1112, a firsttreatment element 1116 disposed at a distal end of first shaft 1114, asecond shaft 1118 extending from handle 1112, and a second treatmentelement 1120 disposed at a distal end of second shaft 1118. Firsttreatment element 1116 may include one or more energy delivery orremoval elements. First treatment element 1116 may be configured to beplaced against the tissue of deviation 1104. Second treatment element1120 may include one or more energy delivery or removal elements. Secondtreatment element 1120 may be configured to be placed on an oppositesize of septum 1102 from first treatment element 1116. For example, asillustrated, first treatment element 1116 is placed against deviation1104 in the left nostril, and second treatment element 1120 may beconfigured to be placed against septum 1102 in the right nostril. Secondtreatment element 1120 may act as a backstop, counter-traction element,guide, or otherwise facilitate treatment of deviation 1104 with device1110. In some embodiments, treatment device 1110 includes applicator1106. For example, first treatment element 1116 may include a needleconfigured as applicator 1106 adapted to apply the solution to deviation1104. Other treatment devices may be used.

Using treatment device 1110 to correct deviation 1104 may includeapplying energy to or removing energy from septum 1102 using firsttreatment element 1116 and/or second treatment element 1120. In someembodiments, the application or removal of energy may enhance, inhibit,or otherwise modify the effect of the solution on the cartilage. In someembodiments, the application or removal of energy may deactivate thesolution so it no longer substantially acts on the cartilage. In someembodiments applying energy to or removing energy from septum 1102 mayfurther treat or modify cartilage of deviation 1104.

Using treatment device 1110 to correct deviation 1104 may includeapplying mechanical energy. In some embodiments, first treatment element1116 and second treatment element 1120 may be used to apply mechanicalenergy to septum 1102. For example, a user may squeeze a portion ofhandle 1112, causing first treatment element 1116 and second treatmentelement 1120 to come together and pinch deviation 1104. In someembodiments, first treatment element 1116 moves towards second treatmentelement 1120, pushing deviation 1104 toward and/or against secondtreatment element 1120. Second treatment element 1120 may act as abackstop. In some embodiments, mechanical energy may be used to pushdeviation 1104 beyond flat, such that once device 1110 is removed andtissue of the cartilage heals, deviation 1104 is corrected. In someembodiments, second treatment element 1120 may be configured as a mold.For example, second treatment element 1120 may have a particular shape(e.g., concave or convex) and first treatment element 1116 may have acomplimentary shape or may otherwise be configured to shape deviation1104 against second treatment element 1120.

FIG. 36E illustrates septum 1102 having a corrected deviation 1108.Compared to deviation 1104, corrected deviation 1108 may be a slightlyreduced deviation, a completely removed deviation, or otherwisecorrected. A nose with corrected deviation 1108 may have improvedairflow compared to a nose with deviation 1104.

FIG. 37 illustrates a channel stylus device 1200, which may be used totreat a deviated septum, according to some embodiments. Channel stylusdevice 1200 includes a handle 1202, an elongate shaft 1204 extendingfrom handle 1202, and an elongate treatment element 1206. Elongatetreatment element 1206 may be configured to create channels in adeviation, thereby reducing the deviation and improving airflow.Elongate treatment element 1206 may be further configured to applyenergy to or remove energy from tissue. Elongate treatment element 1206may include a plurality of pairs of bi-polar electrodes 1208. Electrodes1208 may be arranged in a serial alignment along treatment element 1206such that electrodes 1208 are in a line along treatment element 1206.For example, electrodes 1208 may be arranged with the center of eachelectrode 1208 along a longitudinal axis of treatment element 1206.

FIGS. 38A-38C illustrate a method of treating a septum 1210 having adeviation 1212 using channel stylus device 1200, according to someembodiments. FIG. 38A illustrates septum 1210 and deviation 1212 asthough looking into a patient's left nostril. FIG. 38B illustratestreatment element 1206 of channel stylus device 1200 inserted into thenostril and pressing laterally against deviation 1212, thereby reshapingdeviation 1212. As illustrated in FIG. 38B, treatment element 1206 mayapply energy to or remove energy from the tissue of deviation 1212. Thismay facilitate the reshaping of deviation 1212. Before applyingtreatment element 1206 to deviation 1212, a treatment solution may beapplied at or near deviation 1212 to facilitate treatment. By reshapingand applying energy to or removing energy from deviation 1212, themethod may create a treated deviation that persists after treatmentelement 1206 is removed and the tissue of deviation 1212 heals.Reshaping deviation 1212 may include flattening deviation 1212.Reshaping deviation 1212 may include creating air channels, troughs, orother shapes in deviation 1212 to facilitate the flow of air. Such airchannels may be particularly useful for treating posterior-runningseptal deviations. Reshaping deviation 1212 can include increasing anasal cross-sectional area with or without changing a nasal valve angle.Reshaping deviation 1212 can include modifying a nasal valve angle. FIG.38C illustrates a treated deviation 1214 after device 1200 is removedand the tissue of septum 1210 heals. As illustrated, air channels 1216through which air may flow are formed in treated deviation 1214.Compared to deviation 1212, a patient having treated deviation 1214 mayhave improved airflow through the nostril.

FIGS. 39A-39D illustrate a method of treating a deviated septum 1302 bytreating and evacuating cartilage 1304, according to some embodiments.FIG. 39A is a view of a nose having deviated septum 1302. FIG. 39Billustrates an applicator 1306 applying a solution 1308 to cartilage1304. As illustrated, applicator 1306 is an injector injecting solution1308 into or near cartilage 1304. Solution 1308 may be a solution thattreats cartilage by, for example, softening or dissolving cartilage,such as those previously described herein. Other applicators andapplication methods may also be used. After solution 1308 has beenapplied to cartilage 1304, solution 1308 may be given a dwell time inwhich to act on cartilage 1304. After solution 1308 is applied, treatedcartilage 1304 may be further treated, such as by a treatment elementapplying energy to or removing energy from treated cartilage 1304 or bya treatment element applying mechanical force to treated cartilage 1304.The further treatment may be selected to enhance, inhibit, guide, shapeor otherwise modify treatment of cartilage 1304. In some embodiments, aportion of cartilage outside of the treatment area may be treated todenature or otherwise deactivate solution 1308 if it reaches thatportion of cartilage. In some embodiments, the further treatment mayinclude applying energy or force to treated cartilage 1304 to break orfurther weaken cartilage 1304 for ease of removal.

FIG. 39C illustrates an evacuator 1310 evacuating treated cartilage1304. After the treatment or further treatment of cartilage 1304,cartilage 1304 may be in a condition ready for removal. As illustrated,evacuator 1310 may be inserted into septum 1302 and used to applysuction to remove treated cartilage 1304. Other evacuators 1310 andmethods of evacuation may be used. The evacuation of softened cartilage1304 may be performed with or without an incision. In some embodiments,an incision is made and cartilage 1304 is removed through the incision.In other embodiments, no incision is used and instead cartilage 1304 isremoved through a needle inserted into septum 1302. In otherembodiments, there is no active evacuation step. Instead, cartilage 1304may be sufficiently treated that it does not need to be removed; forexample, treated cartilage 1304 may be naturally resorbed by thepatient's body or that cartilage 1304 is sufficiently weak that it nolonger substantially negatively affects airflow. FIG. 39D illustrates atreated nose having a corrected deviation of septum 1302. With deviatedcartilage 1304 removed, septum 1302 is no longer deviated.

Although emphasis has been placed on structure and function of the nasalseptum in much of the foregoing description, modifications of othercartilage or tissue may also be performed based on the abovedisclosures. This may include, but need not be limited to hyaline orother cartilage located in a subject's nose, larynx, trachea, bronchi,airways, ribs, bones, joints, and other locations.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

EXPERIMENTS

Experiments may be carried out to explore ranges in concentration andvolume of solutions applied to cartilage and duration of exposure interms of their efficacy in degrading the cartilage surface.Additionally, the effect of temperature variation on solution activitymay be explored. The aims of the experiments may include: comparing theeffects of collagenase and trypsin (or other enzymes or solutions)exposure on the ability to enhance RF-induced reshaping of nasal septumcartilage and evaluate the effects of particular RF energy exposure toreshape treated nasal septum cartilage.

The efficacy of combined solution exposure and RF treatment may beassessed using bovine nasal septum cartilage obtained from aslaughterhouse. Nasal cartilage samples may be acquired within 24 hoursof slaughter to ensure high cell viability and all protocols below maybe carried out under sterile conditions to enable long term observationof cellular activity after enzyme and RF exposure.

Concentrations, volumes, and durations of exposures for solutions may bechosen based on previous work with articular cartilage. See, e.g.,Griffin et al, Effects of Enzymatic Treatments on the Depth-DependentViscoelastic Shear Properties of Articular Cartilage, J Orthop Res Vol.32, Issue 12, pp. 1652-1657 (2014), incorporated herein by reference forany and all purposes. A range of 0.5 ml to 2.5 ml of enzyme solutionsmay be applied to nasal septum cartilage at concentrations ranging from1-10 mg/ml collagenase and/or 10-100 μg/ml trypsin for times rangingfrom 15 to 90 minutes. In an example, a solution having a concentrationof approximately 40-60 μg/ml trypsin can be applied to nasal septumcartilage and given a dwell time of 30-60 minutes. In an example, asolution having a concentration of approximately 50 μg/ml trypsin can beapplied to nasal septum cartilage and given a dwell time of 40 minutes.In another example, a solution having a concentration of approximately1-3 mg/ml collagenase can be applied to nasal septum cartilage and givena dwell time of approximately 15-25 minutes. In an example, a solutionhaving a concentration of approximately 2 mg/ml collagenase can beapplied to nasal septum cartilage and given a dwell time ofapproximately 20 minutes. Such treatments may be expected to result in anarrow band of degraded cartilage ranging from 100 μm to 1 mm from thecartilage surface. Additionally, prior to application of the solution tocartilage, solutions may be prepared at 20° C., 37° C., 60° C., and 80°C. to document the efficiency of degradation at room temperature, bodytemperature, a temperature consistent with the current operation of theRF probe, and a temperature in excess of the current operation of the RFprobe. Immediately after solution exposure, the thickness of all samplesmay be measured and subset of samples may be characterized by live/deadstaining, histology and microscopy, and mechanical analysis by confocalelastography.

Remaining samples may be shaped using the RF probe, using standardoperating conditions (e.g., sufficient RF wattage to produce atemperature of 60° C. and application of 0.5 kg of force to the tissuefor 30 seconds). Immediately after application of RF energy, thethickness of all samples may be measured and subset of samples may becharacterized by live/dead staining, histology and microscopy, andmechanical analysis by confocal elastography (see below fordescriptions).

The remaining samples may be maintained in sterile culture at 37° C. inDMEM with 10% fetal bovine serum in a 5% CO2 atmosphere for times up to1 week. After culture, these remaining samples may be characterized bylive/dead staining, histology and microscopy, and mechanical analysis byconfocal elastography (see below for descriptions).

Experimental Procedure

The experiment may explore the combination of controlled application ofderivative solutions and RF energy to nasal cartilage to enablereshaping of a nasal septum.

Tissue Isolation, Live/Dead Staining

Bovine nasal septa are obtained from a local slaughterhouse within 24hours of slaughter. Cartilage from the nasal septum is dissected understerile conditions and cut to produce slabs of tissue 1 cm×1 cm×2 mmthick. Prior to use in experiments, tissue slabs are cultured in DMEMwith 10% fetal bovine serum with 100 μg/ml penicillin and 100 U/mlstreptomycin.

Prior to experiments, sample thickness is measured with digitalcalipers. Digital photographs are recorded. After solution exposure, RFexposure, and post-exposure culture, a subset of samples are bisectedand stained with a commercial live/dead kit (such as those provided byInvitrogen, Inc.). Samples are be exposed to 0.15 μm calcein AM and 2 μmethidium homodimer-1 (EthD-1) for 60 minutes at room temperature. Thestained samples are analyzed under a microscope equipped with anepifluorescence attachment (e.g., a Nikon TE2000-S) and a digital camera(e.g., a Spot RT digital camera).

Histology and Microscopy

To assess structural and compositional features of nasal septumcartilage after exposure to the solution, RF exposure, and post-exposureculture, a separate subset of samples are fixed in neutral formalin andprocessed for histology and Fourier Transform Infrared (FTIR)microscopy. To assess collagen structure in nasal cartilage samples,fixed samples are embedded in paraffin, cut into thin sections, anddewaxed in three xylene baths for 2 minutes each, rehydrated in threebaths of ethyl alcohol (100%, 95%, and 70% ethanol, respectively,appropriately diluted with distilled water) for 2 minutes each, and dyedwith Picrosirius red for 1 hours. This histochemical stainingselectively binds to fibrillar collagen, enhancing tissue birefringence.Once prepared, samples are placed on a bright-field microscope with a 4×objective and two independently rotating linear polarizers set 90°apart. Incident light is polarized, passed through the sample, and thenpassed through a second polarizer, producing a map of the localbirefringence.

FTIR microscopy is used measure the local composition of proteoglycanand collagen within these samples, as described by our group previously.See, e.g., Silverberg et al, Structure-Function Relations and RigidityPercolation in the Shear Properties of Articular Cartilage, BiophysicalJournal, vol. 107, pp. 1721-1730 (2014), incorporated herein byreference for any and all purposes. Sections, 4 mm thick from eachtissue sample, are be placed on 2-mm-thick mid-infrared (IR) transparentBaF₂ disks that are 25 mm in diameter. Sections are dewaxed andrehydrated as described above. Samples are loaded into a Fouriertransform infrared imaging (FTIR-I) microscope (e.g., a Hyperion 2000FTIR-I microscope) in transmission mode set to acquire data onwavenumbers between 600 cm⁻¹ and 4000 cm⁻¹ with a resolution of 4 cm⁻¹.A 15× objective is used with a slit aperture configured to acquirespectra over a rectangular region 25×200 mm². Fifteenbackground-corrected scans are repeated at a given measurement point andaveraged to generate a single IR spectra. The acquisition window istranslated along the tissue thickness by a computer-controlled stage toacquire measurements at 80 points spaced 25 mm apart.

The two primary solid-matrix contributions to nasal septum come fromtype II collagen and aggrecan. Hence, pure compound spectra where bothcompounds were extracted from bovine articular cartilage is used. Eachspectra is fit to a linear combination of a type II collagen spectrum,an aggrecan spectrum, and a linear baseline over the spectral windowfrom 900 cm⁻¹ to 1725 cm⁻¹. The final product of this fit is a local mapof collagen and proteoglycan concentration in solution- and RF-treatedcartilage, which enables the determination of any compositional changesinduced by these treatments.

Confocal Elasography

To assess the individual and combined effects of solution treatment andRF energy delivery to cartilage on the local mechanical properties ofcartilage, grid-resolution automated tissue elastography (GRATE) is usedto map local strains in repair cartilage. See, e.g., Buckley et al,High-Resolution Spatial Mapping of Shear Properties in Cartilage, J.Biomechanics, vol. 43, pp. 796-800 (2010); see also Buckley et al,Mapping the Depth Dependence of Shear Properties in Articular Cartilage,J Biomechanics vol. 41, pp. 2430-2437 (2008), each incorporated hereinby reference for any and all purposes. For this analysis, samples ofbovine septal cartilage obtained from experiments described above is cutlongitudinally exposed to 7 μg/mL 5-dichlorotriazinylaminofluorescein(5-DTAF) for 2 hours to uniformly stain the extracellular matrix.Samples are placed in a tissue deformation imaging stage (TDIS) andmounted on an inverted confocal microscope (e.g., the Zeiss LSM 510)where gridlines with a spacing of 50 μm are photobleached on the sampleusing a 488 nm laser. A series of steps in compressive strain areimposed on the sample via the TDIS, and at each compressive strain, aseries of sinusoidal shear displacements are imposed on the sample atfrequencies ranging from 0.001 Hz to 1 Hz. During the application ofcompressive and shear displacements, load cells mounted on the TDIS willrecord the resultant forces. Simultaneous to this, images of the sampleare acquired at 20 Hz. Using custom image analysis MATLAB code, theintensity minima corresponding to the location of the photobleachedlines is tracked, and the local strains are determined from the slopesof these photobleached lines. At 20 μm layers through the tissue thelocal modulus are calculated from the measured loads and local strains.

The result of these studies is a characterization of the treatment ofnasal septum cartilage that change the shear properties of the tissue.This technique enables the description of the strain field on a lengthscale of 20 μm×20 μm, which is on the order of 1% of the tissuethickness. This data combined with that obtained from histological willgives insight into how cartilage reshaping techniques affects the localstructure and properties of the tissue.

Although emphasis has been placed on structure and function of the nasalseptum in much of the foregoing description, modifications of othercartilage or tissue may also be performed based on the abovedisclosures. This may include, but need not be limited to hyaline orother cartilage located in a subject's nose, larynx, trachea, bronchi,airways, ribs, bones, joints, and other locations.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

1. A method for modifying a nasal septum of a subject's nose withoutforming an incision or removing tissue, the method comprising: injectinga substance under nasal mucosa and into contact with cartilage of thenasal septum, wherein the substance is configured to modify a propertyof the cartilage, and wherein the substance is selected from the groupconsisting of collagenase, hyaluronidase, tosyl lysyl chloromethane,trypsin, and trypsin/EDTA; inserting an elongate treatment element of abipolar radiofrequency energy delivery device into the subject's nose,wherein the elongate treatment element comprises two rows of bipolarelectrodes; applying force to the nasal septum with the elongatetreatment element, to change a shape of the cartilage of the nasalseptum; applying radiofrequency energy to the cartilage of the nasalseptum at a selected tissue depth by transmitting the radiofrequencyenergy from a first row of the two rows of bipolar electrodes to asecond row of the two rows, while continuing to apply force to the nasalseptum with the elongate treatment element; and removing the elongatetreatment element from the subject's nose, wherein the shape of thecartilage of the nasal septum remains changed after the elongatetreatment element is removed.
 2. (canceled)
 3. The method of claim 1,wherein the substance is configured to soften the cartilage of the nasalseptum.
 4. The method of claim 1, wherein the substance is configured todissolve proteoglycan structures of the cartilage.
 5. The method ofclaim 1, wherein the substance comprises about 0.5 ml to about 2.5 ml ofcollagenase at a concentration of about 1 mg/ml to about 10 mg/ml. 6.The method of claim 1, wherein the substance comprises between about 0.5ml to about 2.5 ml of trypsin at a concentration of about 10 μg/ml toabout 100 μg/ml.
 7. The method of claim 1, further comprising allowingthe substance to reside on the nasal septum for a period of time beforeapplying the radiofrequency energy to the cartilage of the nasal septum.8. The method of claim 7, wherein the period of time is between 15minutes and 90 minutes.
 9. The method of claim 7, wherein the period oftime is selected to be sufficient for the substance to create a band ofdegraded cartilage ranging from 100 μm to 1 mm from a surface of thecartilage.
 10. (canceled)
 11. The method of claim 1, wherein injectingthe substance comprises injecting into a space between the nasal mucosaand the cartilage.
 12. The method of claim 1, further comprisingdefining an area of application of the substance by providing a physicalbarrier to contain the substance.
 13. The method of claim 1, whereinapplying the radiofrequency energy to the cartilage of the nasal septumcomprises heating the cartilage.
 14. The method of claim 13, whereinheating the cartilage of the nasal septum comprises heating thecartilage to a temperature selected to denature or deactivate thesubstance.
 15. (canceled)
 16. The method of claim 1, wherein changingthe shape of the cartilage comprises correcting a deviation of the nasalseptum. 17.-19. (canceled)
 20. The method of claim 17, furthercomprising: inserting a reshaping device into the patient's nose, suchthat a first treatment element of the reshaping device is positioned onone side of the nasal septum and a second treatment element of thereshaping device is positioned on an opposite side of the nasal septum;and reshaping the nasal septum using the first treatment element and thesecond treatment element at least one of before, during or afterapplying the radiofrequency energy.